Senior Quality Engineer – Design Assurance

Senior Quality Engineer – Design Assurance (Firmware / Electrical Systems)

An innovative, well-funded medical device company is developing next-generation implantable technology that is transforming patient outcomes. With significant recent funding, multiple active development programs, and new manufacturing capabilities coming online, this is an exciting opportunity to join a growing organization at a pivotal stage!

What You'll Do

• Serve as a Design Assurance subject matter expert supporting multiple new product development projects.
• Review engineering changes and assess quality, validation, and testing impacts.
• Develop and execute test strategies for firmware, electrical, and system-level product changes.
• Partner closely with R&D, software, firmware, manufacturing, and quality teams throughout the product lifecycle.
• Review verification and validation documentation to ensure regulatory compliance and product quality.
• Support risk management activities, CAPAs, complaint investigations, and continuous improvement initiatives.
• Contribute to manufacturing process validation and future in-house manufacturing expansion efforts.

What We're Looking For

• Bachelor's degree in Electrical Engineering or related technical discipline.
• 7+ years of Quality Engineering, Design Assurance, Product Quality, or related experience.
• Strong electrical systems and/or PCB (printed circuit board) experience is required.
• Experience developing test methodologies and evaluating the impact of design changes on product performance.
• Ability to review and understand firmware and Python-based test scripts (coding expertise not required).
• Experience supporting verification, validation, and design control activities.
• Strong problem-solving skills with the ability to think creatively and propose practical solutions.
• Medical device experience is preferred but not required; candidates from highly regulated industries will be considered.

Preferred Background

• Class III medical devices, implantables, cardiac rhythm management, pacemakers, or neuromodulation.
• Capital equipment or hospital-based medical technologies.
• Contract manufacturing environments supporting complex electronic products.

Why Join?

• Innovative, life-changing technology with direct patient impact.
• Multiple active development programs and strong product pipeline.
• Significant recent funding and long-term growth runway.
• Highly collaborative, cross-functional engineering culture.
• Opportunity to influence products from development through commercialization.
• Hybrid work environment (3 days onsite) with flexibility and strong work-life balance.

Compensation

• Base salary: $130,000 - $160,000
• Annual bonus opportunity
• Equity participation
• FULL medical, dental, and vision coverage