Senior Medical Device Engineer | Blue Arbor Technologies

Senior Medical Device Engineer

1099 Independent Contractor  ·  Hybrid – Ann Arbor, MI  ·  Competitive Rate

Blue Arbor Technologies is translating a Class III implantable neurostimulation device from laboratory prototype to FDA-approved, commercially manufactured product. This is a foundational engineering role — the person who fills it will set the technical and cultural tone for how we build. We are looking for a Senior Medical Device Engineer who leads by doing and who holds quality and patient safety as non-negotiable commitments.

WHY THIS ROLE MATTERS

You will be the primary engineering owner driving the device from development through commercial manufacturing readiness. The decisions you make — in design control, verification, manufacturing transfer, and regulatory strategy — will determine whether a safe, effective device reaches patients on time. We take that seriously, and we expect you to as well.

WHAT YOU WILL DO

• Lead end-to-end development of a Class III implantable device across hardware, embedded firmware, and software from concept through design transfer.
• Own design control activities: DHF, DMR, design reviews (PDR, CDR, DV/PV), V&V protocols, and risk management documentation.
• Drive FDA regulatory submissions (IDE, 510(k), or PMA), interface directly with the agency, and manage responses to technical queries.
• Lead commercial manufacturing readiness — DFM, process qualification (IQ/OQ/PQ), supplier qualification, and acceptance criteria — in partnership with contract manufacturers.
• Manage cross-functional engineering projects from concept through commercialization: timelines, milestones, resource plans, and risk mitigation.
• Ensure full compliance with FDA 21 CFR Parts 820 and 812, ISO 13485, and ISO 14971 across all engineering activities.
• Mentor junior engineers and contribute to building an engineering culture defined by quality, accountability, and transparency.
• Report directly to and partner closely with the CTO on product and strategic direction.
  
  

WHAT YOU BRING

• Bachelor's degree (required) or Master's degree (preferred) in Biomedical, Electrical, or Mechanical Engineering, or a closely related discipline.
• Minimum 7 years of progressive medical device engineering experience, including at least 3 years on Class III implantable devices.
• Demonstrated hands-on experience with hardware, firmware, and/or software development for implantable neurostimulation or similar complex electronic devices.
• In-depth knowledge of FDA 21 CFR Parts 820 and 812, ISO 13485, and ISO 14971.
• Proven track record managing full design control cycles in a regulated environment.
• Direct FDA submission experience (IDE, 510(k), or PMA) is strongly preferred.
• Familiarity with biocompatibility (ISO 10993), sterilization validation, and packaging standards (ASTM F2475 / ISO 11607).
• Startup experience and demonstrated ability to operate with autonomy and high ownership are a significant plus.
  
  

ENGAGEMENT DETAILS

• 1099 independent contractor engagement — competitive hourly or project rate commensurate with experience.
• Full-time, hybrid arrangement; 2 – 3 days per week on-site in Ann Arbor, MI.
• Occasional travel to contract manufacturers, test facilities, clinical sites, or regulatory agencies may be required.

This is an opportunity to help build something that matters — from the engineering foundation up. If that challenge energizes you, we would like to talk.

How To Apply

Interested candidates should email their resume and cover letter to tborton@outlook.com.