Lead Quality Engineer

A repeat well‑funded, clinical‑stage medical device client of ours is developing a breakthrough technology poised to redefine standards of care in the gastrointestinal space. The organization is entering a critical growth phase, and looking for a Lead Quality Engineer to be at the center of engineering, product development, and manufacturing compliance activities.

As a key member of a highly experienced, mission‑driven technical team, you will directly influence the quality, reliability, and scalability of a first‑in‑class device currently progressing toward commercialization. The company has a track record of fostering collaborative, empowered work environments where engineers can innovate, problem‑solve, and see their contributions rapidly translated into patient impact.

Previous placements have consistently enjoyed competitive compensation packages, strong medical benefits, and the opportunity to contribute meaningfully to a life‑changing medical platform.

In this role, you will specialize in manufacturing compliance for a Class II medical device, helping bridge engineering, R&D, quality, and external manufacturing partners. Your responsibilities will include:

• Leading manufacturing compliance activities (not a traditional QA-only role)
• Contributing across engineering, R&D product development, manufacturing, and design transfer
• Owning and executing Design & Process V&V, DHF updates, protocol development, and risk documentation
• Managing CAPAs, product testing, validations, and compliance deliverables
• Reviewing, maintaining, and improving risk management files
• Partnering with contract manufacturers to ensure scalable, robust, and compliant manufacturing processes
• Leading complaint review, root cause investigation, and related documentation
• Traveling to CMOs in Michigan and China approximately 1-2 times per year

The ideal candidate brings a mix of technical expertise, hands‑on execution capability, and comfort operating in a fast‑moving startup environment.

• Degree in Manufacturing, Biomedical, Mechanical, Chemical, or Polymer Engineering
• 10+ years of medical device industry experience
• Experience working with Class II devices, preferably catheter‑based or cardiovascular‑type products
• Strong familiarity with medical device design controls, risk management, V&V, and compliance frameworks
• Experience supporting or leading design transfer to manufacturing
• Ability to operate independently, work cross‑functionally, and "wear many hats" as needed
• Demonstrated success collaborating with external manufacturing partners (domestic and international)

• Clinical-stage, first‑in‑class GI technology with strong funding and clear market need
• Ability to step into a high‑impact, highly visible engineering role
• Work alongside deeply experienced technical leaders who value innovation, transparency, and accountability
• Growth trajectory provides opportunities for expanded responsibility and leadership
• Mission‑driven culture focused on improving patient outcomes and advancing GI care

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct‑hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.

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