Electrical/Software Engineer IV
Ann Arbor, MI
MC3 Cardiopulmonary is dedicated to developing and manufacturing innovative and effective new extracorporeal life support (ECLS) technologies that will be used to treat severe heart and lung failure. We have experienced high growth over the past few years and have a state-of-the-art production facility and have launched several successful products. This growth is expected to continue as we seek to become the ECLS market leader.
Working as a technical leader, responsible for providing technical leadership on new and existing medical devices from ideation through product commercialization. May take on leadership role of medium to large new product development or product sustaining projects.
- Technical expert responsible for design and development oversight in compliance with IEC 60601 3rd edition and IEC 62304
- Works independently and in collaboration with internal and external resources, to provide technical design solutions for new and existing products. Will operate in a matrix environment and may work on new product and sustaining efforts simultaneously
- Provides oversight to internal and external resources to assure electrical and software-based design solutions are developed, implemented, tested and documented in accordance with applicable standards and in compliance with international regulatory requirements and consensus standards for medical devices
- Researches engineering principles that can improve the performance of existing MC3’s existing products and/or build the company's IP portfolio
- Maintains awareness of medical device industry trends and technologies.• Prepares project proposals, project plans, and reports for assigned new product, sustaining and grant sponsored projects
- May serve as cross functional project manager on select projects
- Assures compliance with MC3 Quality System including the Product Development Procedure and other related procedures including Design Control and Risk Management
- Applies technical skills and experience in designing finished products, sub-systems, and components of medical devices of moderate to high complexity. Assures effective design transfer into manufacturing
- Establishes or oversees creation of test plans and as necessary and participates in tests and evaluations of products and components throughout the product lifecycle.
- Authors and/or approves key documents comprising the design history file. Assists in developing plans and documentation for regulatory submissions
- In product/technical areas of demonstrated subject matter expertise, may assist marketing in obtaining customer inputs for new products and providing field support for existing products. Assume leadership role as technical project lead for new product realization efforts
- Bachelor’s Degree in Engineering or equivalent combination of education and experience
- 7 years related experience (5 years with Masters, 3 years with PhD)
- Experience in project execution against various standards including ISO/IEC 60601, 62366 and 62304
- Demonstrated analytical and problem-solving skills• Excellent written and communication skills
- Demonstrated ability of working on multiple projects in a deadline driven environment
- Works effectively both independently and as a member and/or in leadership of a cross functional project team
- Demonstrated experience generating technical documentation such as product requirements, specifications, engineering reports, test plans & procedures, validation plans, or validation reports.
- Experience in medical device design, development, verification, and documentation
- Experience with development in a regulated industry such as medical device, defense, or automotive
- Experience in embedded devices design, development, verification, and documentation
- Experience in requirements development, analysis, allocation, review, and tracing
- Demonstrated experience in embedded in electro-mechanical medical device product development
Download the PDF file for position responsibilities and qualifications
Quality System Interaction:
- This position is within an industry regulated by the Food and Drug Administration of the United States Government, as well as by other US and non-US regulatory agencies. Compliance to all applicable regulations is mandatory.
- The activities of this position can and may impact the safety and effectiveness of a medical device which, in turn, can impact the lives of other persons.
- As an employee, you are responsible for maintaining performance consistent with the stated quality policy and procedures of MC3. Improper performance may affect device quality, patient safety, regulatory compliance, and company performance.
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