Reports to: Vice President, Engineering Location: Madison WI Area
The Systems Engineer will play a key role in supporting the design, technology development, product definition, testing, and documentation of Beyond Air products. They will collaborate with a diverse team of engineers and work in a dynamic and fast-paced environment. This individual will support systems engineering related activities on product development programs, guiding integration with software electro-mechanical systems.
- To support systems engineering efforts for a complex, software-driven medical device; responsibilities may include managing parts flow, system builds (including hardware assembly and integration), software loads and updates, configuration control, and test execution and reporting.
- Supporting a cross-functional design transfer process to ensure the product designs are manufacturable and serviceable
- Supporting product sustaining activities including value engineering, reliability improvements, manufacturability improvements, field issues with technical and impact analysis.
- Owns and drives resolution of design issues/defects both electrical and mechanical, under guidance from senior R&D engineers
- Translate customer needs into requirements and engineering specification as documenting design input and output.
- Collaborate and support the development and maintenance of design history files (i.e. product specifications), hazards analysis documents, usability and other technical documentation.
- Perform complaint, failure and Risk Management activities, develop risk mitigation strategies to ensure that design or process shortcomings are identified and appropriately addressed.
- Perform Risk Analyses, including Fault Tree Analysis (FTA), Operator Misuse Analysis (OMA), and Failure Mode and Effects Analysis (FMEA) activities.
- Provide technical guidance for product design, manufacturing, service, development, integration, testing, and reliability improvements.
- Provide system level solutions required to meet Electromagnetic regulatory compliance.
- Performs product tests to confirming compliance to regulatory standards.
- Works on problems of moderate scope where analysis of situation or data requires a review of a variety of factors for determination of root cause.
- Exercises judgment within defined procedures and practices to determine appropriate action.
- Work closely to respond rapidly to emerging issues for released product in the field, production, quality, engineering, and supply chain of key components.
- Create and review manufacturing assembly or test process, design, and fixture documentation including assembly work guidelines, specifications, and CAD models / drawings.
- Perform engineering, integration, verification and validation testing, including protocol development, report generation and change regression analysis.
- BSc in Engineering, Biomedical Engineering, Electrical, or Mechanical (Masters preferred)
- MS preferred
- Minimum 10 years of relevant experience in a medical device Company is a plus
- 2+ years as a Systems Engineer on Product Design, development and/or testing medical devices
- Experience in the Respiratory field specifically supporting Nitric Oxide products / devices highly desirable.
- Understanding of medical device product design and regulatory processes.
- Able to communicate effectively, both verbally and in writing.
- Experience with medical device design and development processes that conform to standards including: ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971.
- Strong understanding of system design, electronics, mechanical and software integration.
- Strong understanding of working principle of sensor technologies and electro-mechanical assemblies
- Broad experience with laboratory test instrumentation, electrical test equipment, test methods for reliability HALT and HASS or related verification data analysis activities.
- Knowledge of design of experiments
- Technical understanding of and experience with best-practice product development methodologies.
- Ability to independently manage and prioritize work based on goals and objectives and provide deliverables in alignment with timelines and deadlines.
- Medical Device Manufacturing experience
- Medical device product development experience from concept phase to device production
- Experience with design & testing for manufacturing assembly and test
- Experience with electronic design and systems level electro-mechanical packaging
- Experience with pneumatic gas delivery control systems used in medical life support equipment
- Work outside the normal office hours as required.
- Mission-Driven & Committed
- Team Oriented
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.
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