Reports to:     Director, Clinical Services                         Location:        California

Job Summary

Working under minimal direction, provides educational, technical and customer support for clinical issues concerned with the safe and correct implementation of Beyond Air medical devices. Engage and work closely with stakeholders (physicians, health care professionals, patients, and commercial team) involving Beyond Air products. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes.

Accountabilities

• Has a basic understanding of the competitive landscape in nitric oxide delivery devices
• Demonstrates ability to build and sustain clinical support relationships with customers and shares product expertise accordingly.
• Evaluation of new devices and review of all associated educational and support material provided to customers.
• Identifies, reports and advises of customer needs and product performance to the field-based teams / directors and/or management
• Develops, leads and/or facilitates trainings and other programs on Beyond Air products to healthcare professionals.
• Provides insight, guidance, and feedback to management on market feedback and components for future or next generation of products.
• Continuously develops clinical and technical skills and supports the commercial team strategic plans in patient care clinical trials
• Completes other tasks as necessary

Activities:

• Provide in-person or video-supported training to medical personnel in the hospital or clinic setting.
• Provides on-call support as needed on evenings and weekends post sign-off
• Operational Support
• Helps manage customer inventory needs and requests as required
• Provides education and clinical support in response to clinical field inquiries on as-needed basis. Demonstrates a thorough command of all products, related products and technical knowledge.
• Assist with Beyond Air device investigations on clinician-reported performance issues.
• Trouble Shooting
• Provides back-up support to Sales & Customer Support Representatives in the following areas:

• Internal Training
• External device training to Physicians, Nurses and Respiratory Therapists
• Clinical studies/data collection.

Requirements:

• Registered Respiratory Therapist, BSc
• Minimum 8-10 years of experience in respiratory medical device clinical support.
• Minimum 5 years clinical experience in an ICU environment.
• Experience in the Respiratory field specifically supporting Nitric Oxide products / devices highly desirable.
• Demonstrated knowledge of wide range of respiratory therapy devices and treatments
• Familiarity with respiratory therapy procedures and protocol.
• Demonstrated advanced knowledge nitric oxide delivery systems is highly preferred.
• Must have comprehensive written and verbal communication, interpersonal, presentation, analytical, organizational skills, and the ability to meet deadlines.
• Must have the ability to concentrate on detail and work independently.
• Must be able to work effectively with engineers, technical specialists, vendors, and customers to achieve assigned goals; must be capable of coordinating multiple assignments simultaneously and effectively.
• Must possess comprehensive computer skills (experience with Microsoft Word, Excel, Powerpoint or equivalent required).
• Self-motivated and able to work independently, whilst maintaining inclusive approaches.
• Excellent time management skills and ability to work under pressure to deadlines.
• Must exhibit high quality, ethical and work habits.

EEO Statement:

Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Reports to:       Vice President, Engineering                                Location:              Madison WI Area

Job Summary

The Electrical Engineer provides day-to-day support of Engineering product development activities for existing and new medical device programs. This person will be hands on, adept with hand tools for soldering, electrical measurement equipment and have strong attention to detail with the ability to work with moderate supervision.  Medical device development or service repair containing electronics, various sensors, electromechanical actuators and pneumatics experience is preferred.

Accountabilities

• Provides technical support when needed, while adhering to all applicable procedures
• Uses a variety of test equipment/instruments, assists in maintaining acceptable performance of equipment/instruments (e.g. calibration/verification) and assists in keeping applicable procedures updated
• Build a strong understanding of Nitric Oxide Gas Delivery system field of operation to provide root cause troubleshooting for field product complaint diagnosis.
• Evaluate and select components, generate component specifications
• Support Manufacturing in troubleshooting operations involving medical devices through assembly and test
• Provide technical assistance to other functional departments such as Product Engineering, Systems Engineering, Mechanical Engineering, Software Engineering, Quality, Reliability and Manufacturing
• Supports CAPAs, cost reduction, EOL and continuous improvement of products
• Comply with all standards and exercise regulatory compliance requirements such as FDA QSR and ISO 13485

Activities:

• Works in conjunction with the Engineering team to support manufacturing scale-up, incorporate new design changes, vended component qualification and make manufacturing improvements.
• Uses CAD for the creation of design output drawing to support the supply of components and mechanical assemblies.
• Perform hands-on mechanical design of a pneumatic gas delivery control systems used in medical life support equipment
• Performs engineering calculations to support design work
• Collaborates with a multi-disciplinary engineering teams in support of electro-mechanical packaging of electronics, sensors combined with pneumatics.
• May assist in preparation of materials for in-process and final verification testing, including, but not limited to medical devices. This can include component sampling, testing, measuring, recording and analyzing results.
• Work as part of a team under the direction of Development & Research Engineering and assist with New Product development feasibility testing, construction, assembly, troubleshooting the repair of electronics and electromechanical systems during the design process
• May assist, as required, with activities regarding incoming raw material inspection, in-process inspection, finished product or component inspection, and/or non-conformance reporting
• Assist with internal and external (regulatory or customer) audits, as appropriate
• Utilizes established mathematical or scientific statistical analysis techniques to compile and analyze engineering data
• Writes technical reports detailing procedures, outcomes, and observations, as directed
• Maintain orderly engineering laboratory ensuring an efficient but safe work environment
• Collaborate with manufacturing, operations and engineering functions to troubleshoot and resolve manufacturing issues, and facilitate transition of manufacturing activities to the operations group.
• Review manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
• Any other duties as assigned
  
  

Requirements:

• BSEE equivalent degree in an Engineering Discipline (Masters preferred)
• Minimum 5+ years of relevant experience in a medical device Company or related field
• Good Communication skills and an eye for detail are required
• Knowledgeable in Design Engineering, New Product Development, trouble-shooting and repairs related to medical device design and manufacturing.
• Ability to read electrical schematics and electropneumatic system diagrams
• Understanding of electrical engineering test equipment
• Understanding of electrical engineering principles for sensors, electromechanical actuators.
• Understanding of electronics for both analog, digital embedded processor power, power regulation and current control.
• Knowledge of ISO 13485/FDA requirements
• Experience with electro-mechanical devices: Previous work with pressure sensors, flow sensors, solenoids, power supplies, motor control, and transducers.
• C and Verilog experience
• Experience with Design Controls, electronic components, Failure Analysis
• Computer literate with an excellent working knowledge of Microsoft Office, including Word, Excel, and Databases.
• Strong mathematical skills are required  

EEO Statement:

Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Head of Clinical Research and Development

The Head of Research and Clinical Development will report to the CMO and will be responsible for leading clinical strategy and development across the Beyond air program portfolio. This role will provide medical oversight for studies with a focus on safety. This role oversees data generation in house and with CROs and collaborators meeting the highest standards scientifically and ethically to enable highly effective regulatory interactions. This individual will lead the clinical development programs for branded products, as well as provide key subject matter expertise to portfolio expansion and business development opportunities.

Key Responsibilities:

• Responsible for the preparation of the Global-initiated clinical development plans, medical input to Investigator’s Brochures, study protocols, study reports, clinical components of IND/IDE and NDA/PMA applications.
• Establish and assess the strategy for clinical trial planning, design, execution, and analysis with assurance of alignment with regulatory activities.
• Contribute to assessment of medical safety in clinical trials
• Coordinate with Regulatory Affairs to ensure adequate input into clinical dossiers and labelling matters. Participate in FDA and Scientific Advisory Committee meetings. Provide annual IND clinical updates.
• Lead a team focused on the clinical development programs associated with the branded products and business development opportunities.
• Advise clinical team on protocol development and execution
• Interact with internal and external stakeholders for the clinical strategy and study operations, inclusive of external engagement with consulting healthcare professionals, trial site investigators, Contract Research Organizations, and other vendors.
• Identification and maintenance of key resource support to the clinical project managers for study execution, project management, program management, data integrity, and medical writing.
• Accountability for Clinical R&D compliance with policies, procedures, and standard operating procedures.
• Evaluate and contribute to potential business development opportunities.
• Attend, and if relevant, lead in training curricula, symposia, and conferences in order to maintain medical and leadership expertise associated with Clinical R&D's goals and objectives.
• Communicate effectively with partners, affiliates, and stakeholders to ensure alignment and time-bound clinical and business commitments.
• Adhere to Good Clinical Practice (GCP) and assure the adherence of all clinical team members (internal and external) to GCP.
• Work closely with functional partners to ensure an integrated and strategic approach to flawless execution and systematic oversight of study protocol(s)
• Regularly interact with cross-functional teams to provide input on strategic clinical development issues and clinical trial operations relating to R&D projects.
• Serve as the clinical representative to lead key regulatory discussions
• Ensures adherence to Good Clinical Practices, standards, standard operating procedures and to all other quality standards in conducting research
• Develop high quality and relevant real world evidence data that demonstrate clinical, economic, and humanistic value to healthcare decision-makers.
• Ensure Medical, R&D, and cross organizational alignment on publication strategy.
• Demonstrate a high level of credibility with external KOLs, and internal stakeholders to identify tactical gaps in strategy and utilize understanding of clinical trial design, statistical methods, and clinical data to develop studies and communicate their results to address those deficiencies.
• Driving the medical writing strategy for all clinical programs, and for the provision of managerial oversight
• Leads cross-functional teams to develop a medical communication strategy

Qualifications:

• A minimum of 10 years of experience in clinical research.
• MD/PhD/PharmD required
• Requires proven experience with developing efficient discovery processes and directing complex cross-functional team collaborations.
• Must have a proven track record of advancing programs through discovery, IND-enabling studies and IND filing.
• Demonstrated expertise in therapeutic development process including technical, business, and regulatory issues.
• Evidence of successful ongoing career development and leadership skills; additional Medical, Safety, or other pharmaceutical development experience is preferable. Experience as a project team leader with major responsibility for at least one New Drug Application (NDA) or equivalent device submission desired
• Experience in leading discussions with FDA and other health authorities at all phases of development
• Requires the ability to build strong relationships with key stakeholders.
• Excellent scientific writing and editing as well as written/oral communication skills with several years of professional experience in medical or scientific writing (clinical protocols)
• Experience managing CROs and working within cross functional teams
• Self-starter with ability to learn new disciplines
• Strong analytic skills, problem-solving skills, and medical writing skills. Experience in writing and implementing research protocols, reviewing and interpreting data, preparation of study reports, data analysis, and presenting data to internal and external audiences.
• Ability to think strategically and communicate/problem-solve within a team structure.

EEO Statement:

Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Senior Software Engineer

Reports to:     Head of Software Engineering                      Location:        Madison, WI Area

Job Summary

The Senior Software Engineer designs and develops embedded software solutions for medical products. They are familiar with the software development life cycle (SDLC) from preliminary system analysis to tests and deployment. Ultimately, the role of the Software Engineer is to build high-quality, innovative, and fully performing software that complies with IEC Medical Standards and FDA Guidance.

Accountabilities

• Collaborate with development team to establish requirements
• Develop software to satisfy system and software requirements
• Produce documentation to satisfy IEC Medical Standards and FDA Guidance

Activities:

• Execute full lifecycle software development
• Program well-designed, testable, efficient code
• Produce specifications for architecture and design of device software
• Integrate software components into a fully functional software system
• Collaborate with verification engineers on verification plans and protocols
• Collaborate with electrical and mechanical engineers during system development
• Troubleshoot, debug and upgrade systems
• Deploy programs, develop installation methods and scripts for manufacturing
• Comply with project plans and industry standards
• Any other duties as assigned
  
  

Requirements:

• BS or MS degree in Computer Engineering / Computer Science / Electrical Engineering
• Minimum 10 - 15 years of experience in Software Engineering for a medical device Company
• Languages: C, Python 
• Experience with embedded projects using ARM Cortex Microprocessors
• Experience with multi-processor systems
• Experience with embedded GUIs, testing, and internationalization
• Experience developing unit tests
• Experience with various embedded peripherals such as CAN, SPI, I2C, Serial, DMA, ADC, DAC, Flash
• Experience with NFC and RFID technologies
• Experience with LCD / display interfaces
• Experience developing embedded installation utilities and bootloaders
• Experience as a software technical team lead
• Ability to work independently and drive results
• Ability to travel as needed.
• Work outside the normal office hours as required

EEO Statement:

Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Director, Quality and Regulatory - Europe

 Reports to:     Director, Quality – US                         Location:        Dublin, Ireland

 Job Summary

The Director, Quality and Regulatory Affairs Europe will be responsible for providing quality and regulatory support for the Europe Region as required under the EU MDR Regulations, and other European regulatory authorities. The individual will work closely with and under the direction of the Director of Quality with a dotted line to the VP Regulatory Affairs. Responsibilities include quality management of the global supply chain (including any third-party distributors), being the Company point of contact for the European Regulatory Authorities (PRRC), ensuring necessary regional regulatory policies and procedures are in place and developing regional regulatory strategies for pipeline projects, and having the overall responsibility for maintenance of European product registrations. This position involves both high-level strategic planning as well as hands-on responsibilities to support the growing pipeline and marketed product portfolio.

 Accountabilities

• Collaborate with development team to establish requirements
• Develop software to satisfy system and software requirements
• Produce documentation to satisfy IEC Medical Standards and FDA Guidance
• Responsible for Quality Management of the Global Supply Chain, which includes quality control of third-party distributors. Role will involve establishing the function to efficiently manage the quality onboarding and auditing of the global supply chain, including putting in place the required quality agreements.
• Person Responsible for Regulatory Compliance (EU PRRC) at Beyond Air Ireland Limited.
• Ensure continual Quality System compliance to site QMS, ISO 13485, and MDR.
• Responsible for Notified body (BSI) audits: MDSAP, MDR (Canada, EU, etc.), 13486:2016 outside the US.
• Responsible for regulatory submissions to new European markets for Beyond Air Ireland Limited in collaboration with VP Regulatory.
• Responsible for Vigilance system and Reportability of Adverse Incidents in all markets (Incl.- FSCA, FSN, Complaints, CAPA, Reportability Assessment) in the EU.
• Responsible for post-market surveillance activities outside the US and creation of corresponding documents (PMS Plan, PMS Clinical Follow-up Plan).
• Respond to queries from 3rd party suppliers and distributors related to product performance and quality.

 Activities:

• Part of Global Quality & Regulatory Affairs Team of Beyond Air Inc.
• Lead Product Support member of projects to ensure documented continued device compliance to applicable market regulatory requirements.
• Review and approve product labeling materials for compliance with applicable regulations and standards.
• Participate in internal/external company regulatory/quality audits.
• Managing preparations for audits in the EU-by-EU authorities.
• Lead RA representative for site change management with input into RA metric reporting.
• Maintain currency and accuracy of CE Technical Files aligned with device and process changes. Monitor global market regulatory changes, advise and/ or implement changes (with management approval) to ensure compliance.
• Keeping up to date with local and international legislation and guidelines
• Interpret new Medical Device Regulations and ensure compliance to internal procedures for continuous compliance with all regulatory requirements.
• Maintain up-to-date working knowledge of laws, regulations, and guidelines across the European regulatory authorities
• Prepare regulatory dossiers for submission to Health Authorities and Notified Bodies and for other International Regulatory agencies
• Work closely with US Regulatory Operations on electronic submissions and provide input on format and content of European regulatory submissions
• Creation and management of STED (Summary Technical Document– global standard) Technical Files for all range of devices outside the US, in collaboration with VP Regulatory.
• Leading device approvals in new and established markets in the EU for current and next generation products.
• Input to R&D activities, providing technical and regulatory support to R&D engineers.
• Supporting Marketing, Supply chain logistics and Sales team from a technical and regulatory standpoint.
• Clinical Evaluation Plan and Reports: Creation of Clinical Evaluation Plan and identifying and appraising clinical studies and summarizing information in a Clinical Evaluation Study Report
• Implementation of global regulatory strategy, interaction with multiple departments (Global Regulatory, Quality, Production, Commercial), project teams and regulatory agencies, and focusing on the data that supports the clinical efficacy and safety of products.
• Identifying issues and devising solutions, as well as exploiting potential and taking or directing whatever actions are required to maximize effective output.
• Act as the main Company contact with the European Regulatory Authorities.
• In close collaboration with the GRLs assist in the preparation of meeting requests and briefing documents for European Regulatory Authorities.
• Participate in team preparations for meetings with European Regulatory Authorities.
• In close coordination with GRLs, coordinate and prepare responses to requests for information from European regulatory authorities.
• Work with the appropriate partners within Beyond Air to establish, update, and implement European regulatory policies, standards, and procedures for the Company.
  
  

 Requirements:

• Bachelor’s degree in a scientific or regulatory discipline (Masters Preferred)
• Minimum 7-10 years of experience in European Regulatory for drugs and/or medical devices
• Strong knowledge of EU MDR and experience working directly with European Regulatory Authorities.
• Results-oriented individuals with a strong work ethic and ability to complete projects with minimal oversight; track record of successful Technical File submissions is desired.
• Must be highly proficient in use and knowledge of the English language, grammar and punctuation with strong written communication skills in the form of technical writing abilities and/or editorial experience.
• Integrity, ownership mentality, and a commitment to excellence.
• Excellent organizational skills and ability to work on multiple projects with tight timelines.
• Strong interpersonal skills and desire to work with project teams. 
• Work outside the normal office hours as required

Reports to:     SVP, Clinical Operations & Biometrics          Location:        Remote

Job Summary

The VP, Clinical Pharmacology will be responsible for developing, driving, and implementing (with internal collaborations and working with consultants/external partners) global Clinical Pharmacology strategies across multiple indications. You will be a core member of the program team providing Clinical Pharmacology perspectives and delivering modeling and analyses necessary to evaluate clinical options, enable plans, and optimize development programs. This includes gap analysis, study design, PKPD analysis and modeling, program assessment, and internal collaborations to help execute programs. The successful candidate will bring extensive experience in clinical pharmacology and work cross-functionally with research and clinical teams to drive programs to success.

Accountabilities

• Provide expertise for the design of pre-clinical and clinical studies
• Ensuring/performing appropriate PKPD analysis including population PK, PKPD modeling and simulation, meta-analysis, and disease modeling as required by the program to aid in dose selection, trial design, and/or program decision-making.
• Design, implement, drive, and monitor Clinical Pharmacology strategies.
• Work with internal teams and external partners to execute program team objectives
• Leads clinical pharmacology contributions to all regulatory documents including Investigator Brochures.
• Leads the resolution of clinical pharmacology queries from regulatory agencies, takes a lead role in writing and reviewing responses to regulatory queries.
• Analysis of PK data Directs the planning of all relevant PK-PD analyses.
• Use of innovative analytical methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical trials in collaboration with translational science and statistics (as relevant).
• Full knowledge about the clinical pharmacology profile of NO on which studies are being conducted or which are called for in the protocol.
• Ensuring that there are valid methods for measuring concentration (and any biochemical biomarkers) in the R&D lab.

Activities:

• Participate in implementing model-based device development using quantitative approaches to address complex question arising during development spanning from target validation to analysis and interpretation of results.
• Provides recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc.) to the clinical and development teams and in regulatory documentation.
• Develop and execute modeling and simulation plans when appropriate; use model-based approaches to improve the efficiency of drug development and support dose selection and optimization when appropriate.
• Serve as in-house expert on scientific matters
• Discuss pharmacology, pharmacokinetics and toxicology issues with regulatory authorities in order to convey key concepts and facilitate understanding of both risks and results.
• Contribute to program strategy, protocol preparation, study execution, data review/analysis, study reports, and regulatory document preparation; write and review clinical pharmacology summary documents.
• Oversee vendors and consultants as appropriate.
• May act as clinician for Phase I studies or clinical lead / research project lead for specific NO development projects.
  
  

Requirements:

• PhD in Pharmaconkinetics or Pharmaceutical Sciences or related field
• Minimum 10 years of experience in biopharma industry in a Clinical Pharmacology role
• Proven ability to represent Clinical Pharmacology on project teams
• Experience with FDA regulatory interactions
• Experience partnering with DMPK and translational science colleagues to ensure relevant clinical pharmacology strategy is developed.
• Experience working cross-functionally and working with external partners.
• Strong knowledge of the role of clinical pharmacology in medical device company, including the application of translational pharmacology as well as model-based approaches.
• Ability to perform in fast-paced, dynamic, constantly evolving environment.
• Excellent communication and organizational skills and attention to detail.
• Strong time management skills; ability to prioritize multiple tasks efficiently.
• Work outside the normal office hours as required

EEO Statement:

Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Electrical Engineering Technician

Reports to:     VP Engineering                                              Location:        Madison Area, WI

Job Summary

The Electrical Engineering Technician provides day-to-day support of Engineering product development activities for existing and new medical device programs. This person will be hands on, adept with hand tools for soldering, electrical measurement equipment and have strong attention to detail with the ability to work with moderate supervision.  Medical device development or service repair containing electronics, various sensors, electromechanical actuators and pneumatics experience is preferred.

Responsibilities

• May assist in preparation of materials for in-process and final verification testing, including, but not limited to medical devices. This can include component sampling, testing, measuring, recording and analyzing results.
• Provides technical support when needed, while adhering to all applicable procedures
• Uses a variety of test equipment/instruments, assists in maintaining acceptable performance of equipment/instruments (e.g. calibration/verification) and assists in keeping applicable procedures updated
• Work as part of a team under the direction of Development Engineering and assist with New Product development feasibility testing, construction, assembly, troubleshooting the repair of electronics and electromechanical systems during the design process
• Build a strong understanding of Nitric Oxide Gas Delivery system field of operation to provide root cause troubleshooting for field product complaint diagnosis.
• May assist, as required, with activities regarding incoming raw material inspection, in-process inspection, finished product or component inspection, and/or non-conformance reporting
• Assist with internal and external (regulatory or customer) audits, as appropriate
• Utilizes established mathematical or scientific statistical analysis techniques to compile and analyze engineering data
• Writes technical reports detailing procedures, outcomes, and observations, as directed
• Maintain orderly engineering laboratory ensuring an efficient but safe work environment
• Any other duties as assigned

Qualifications / Requirements / Experience

• Degree in an Electrical Engineering Discipline
• Must have 5+ years experience in Medical Device or related field
• Good Communication skills and an eye for detail are required
• Knowledgeable in Design Engineering, New Product Development, trouble-shooting and repairs related to medical device design, service and manufacturing.
• Ability to read electrical schematics and electropneumatic system diagrams
• Understanding of electrical engineering test equipment
• Understanding of electrical engineering principles for sensors, electromechanical actuators.
• Understanding of electronics for both analog, digital embedded processor power, power regulation and current control.  
• Knowledge of ISO 13485/FDA requirements

Specific Criteria:

• Strong Mathematical skills required
• Based in Madison, Wisconsin Area
• Monday – Friday, 9am – 5pm

EEO Statement:

Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.