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.
- 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
- 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
- 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
Vice President, Engineering
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.