SharkNinja
consumer electronics
SeniorMedicalDeviceComplianceEngineer
“Senior Medical Device Compliance Engineer at SharkNinja. Skills: Medical device design control, Post-market compliance, Risk management, Design History Files (DHFs), Verification and validation. Drive design control execution for multiple concurrent medical device NPD programs, ensuring high-quality, audit-ready technical documentation.. Lead and support the creation, review, and approval of Design History Files (DHFs), including design and development plans, requirements, design reviews, risk m”
Industry & Context.
Pragmatic, creative problem-solving
Hands-on role, Operating within a fast-paced, consumer electronics development environment.
What They're Looking For.
Must Have
Bachelor's or Master's degree in Engineering (Mechanical, Electrical, Biomedical), Quality, or a related technical discipline., 5+ years of experience in design controls, and post-market sustaining of medical devices experience supporting electromechanical medical devices, preferably within consumer electronics or high-velocity product development environments., Deep expertise in design controls and risk management, including ISO 14971, hazard analysis, DFMEA, requirements management, and verification/validation., Experience supporting post-market design changes, including ECNs, root cause analysis, and lifecycle risk management., Experience working with overseas contract manufacturers and distributors, including qualification, process validation review, and ongoing compliance oversight., Working knowledge of biocompatibility, electrical safety, labeling, and component change impact assessments., Communication skills and the ability to operate effectively in a complex, matrixed organization., Pragmatic, detail-oriented mindset suited to fast-paced, innovative-driven environments.
What You'll Do.
Drive design control execution for multiple concurrent medical device NPD programs
ensuring high-quality
audit-ready technical documentation.
Lead and support the creation
and approval of Design History Files (DHFs)
including design and development plans
risk management files
verification and validation plans and reports
ensuring documentation is complete and submission ready.
Translate medical device compliance and regulatory requirements into clear
actionable product and engineering requirements.
Ensure risk management activities including hazard analysis
and test planning in alignment with QMS processes.
Support post-market design changes by driving and reviewing ECNs
and associated verification/validation and documentation updates.
Serve as a hands-on QMS Compliance leader within cross-functional teams
influencing execution through expertise
and clear decision-making in a matrixed environment.
Review supplier qualifications
and manufacturing documentation from OEMs to ensure compliance with medical device requirements.
Support internal audits
and regulatory inspections.
How You'll Work.
Team & Collaboration
Hold yourself and cross-functional teams accountable for delivering best-in-class, safe, and effective medical devices that meet customer, business, and regulatory requirements.; Working closely with Engineering, Product Development, Legal, Program Management, and Quality Engineering, including overseas manufacturing partners.; Serve as a hands-on QMS Compliance leader within cross-functional teams, influencing execution through expertise, collaboration, and clear decision-making in a matrixed environment.
Communication Scope
Communication skills and the ability to operate effectively in a complex, matrixed organization.
Process & Methodology
Drive design control execution for multiple concurrent medical device NPD programs
Applying for this Senior Medical Device Compliance Engineer role?
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