Senior Engineer, Design Assurance

About the Role The Senior Design Assurance Engineer is responsible for ensuring compliance with Design Control procedures and regulations for Software, Firmware and Hardware used in Cochlear Implant Technology. You will partner with a cross-functional product development team as the design assurance representative to ensure the design intent is realized while meeting regulatory requirements.

What You'll Do

• Manage all Design Assurance aspects of multiple related projects to align with schedule, budget, quality and resource objectives.
• Lead simulation of design concepts under expected and worst-case use conditions.
• Communicate project progress, risks, issues and mitigations across and up the organization.
• Identify, interpret and advise on implementation of international standards and related standards.
• Ensure designs meet product specifications, regulatory requirements, and international safety standards.
• Responsible for testing strategy and execution, including feasibility studies, DV&V, human factors and usability engineering.
• Identify and lead process improvements to ensure consistent implementation of internal requirements and external regulations and standards.
• If needed, participate in or lead investigations and analysis of product changes and CAPAs.
• Prepare documentation for and support regulatory submissions.
• Create and deliver training to ensure compliance of medical devices with international standards.
• Mentor, train and provide guidance to newer or less experienced team members.

What We're Looking For

• Bachelor’s degree in Engineering or related technical discipline; training in Design for Manufacturability, Design for Six Sigma, and Lean principles; graduate degree preferred.
• Minimum 8 years of product development and/or design assurance experience, including at least 5 years supporting Class III medical devices, with hands-on testing experience.
• Strong knowledge of U.S. and international medical device regulations and quality systems and experience working with regulatory agencies during audits.
• Ability to work effectively in cross-functional matrix organizations, collaborate with diverse stakeholders, multitask in fast-paced environments, adapt to changing priorities, and lead through quality-focused decision-making.
• Excellent analytical, problem-solving, communication, and technical skills; drive results, maintain accountability, attention to detail, and effective written and verbal communication.
• Broad technical expertise across Mechanical, Electrical, Biomedical, and Systems Engineering, Materials Science, Biology, Neurophysiology, and Statistics; experience in cochlear implants, medical device electromechanical systems, biomedical restoration technologies.
• Proficiency in English, Microsoft Office, Minitab (or equivalent), and SolidWorks CAD (or equivalent); second-language proficiency, Agile PLM experience, and other PLM systems a plus.
• Internet connectivity: minimum 200 Mbps download and 10 Mbps upload to support remote/hybrid functionality.
• AI tools such as ChatGPT, Gemini, and Claude considered advantageous.

Nice to Have

• Experience with cochlear implants or related medical device electromechanical systems and biomedical restoration technologies.
• Familiarity with AI tools and platforms as advantageous.

Compensation & Benefits

• Medical, dental and vision coverage.
• Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts.
• TeleHealth options.
• 401k plan with company match.
• Company paid life/AD&D insurance; additional supplemental life/AD&D coverage available.
• Company paid Short/Long-Term Disability coverage; Buy-ups available.
• Accident/Hospital Indemnity.