Senior Medical Device Compliance Engineer

About Us

SharkNinjais a global product design and technology company with a diversified portfolio of 5-star rated lifestyle solutions that positivelyimpactpeoples lives in homes around the world. Powered by two trusted global brands Shark and Ninja the company has a proventrack recordof bringing disruptive innovation to market and developing one consumer product after another has allowedSharkNinjato enter multiple product categories driving significant growth and market share gains. Headquartered in Needham Massachusetts with more than4100associates the companys products are sold at key retailers online and offline and through distributors around the world.

AI at SharkNinja

At SharkNinja were building an AI-native culture. Were not waiting for the future; were creating it. Our people are expected to experiment boldly adopt new tools and continuously raise whats possible to create meaningful impact for our consumers. If you believe the best way to do your job hasnt been invented yet youll fit right in.

Senior Medical Device Compliance Engineer

Needham MA United States

The Senior Medical Device Compliance Engineeris responsibleformedicaldevicedesign control and post-marketcomplianceacrossSharkNinjasMedical Devices portfolio. This role is hands-on and central to ensuring medical device products aredeveloped andsustainedin compliance with global regulatory requirementswhileoperatingwithin a fast-paced consumer electronics development environment.

In this role you will hold yourself and cross-functional teams accountable for delivering best-in-class safe and effective medical devices that meet customer business and regulatory requirements. You will apply best practices and pragmatic creative problem-solving to support high-speed product development working closely with Engineering Product DevelopmentLegalProgramManagement and Quality Engineering including overseas manufacturing partners.

Key Responsibilities

• Drive design control execution for multiple concurrent medical device NPD programs ensuring high-quality audit-ready technical documentation.

• Leadand supportthe creation review and approval of Design History Files (DHFs) including design and development plans requirements design reviews risk management files verification and validation plans and reports and traceability ensuring documentation is complete andsubmission ready.

• Translate medical device compliance and regulatory requirements into clear actionable product and engineering requirements

• Ensurerisk management activities including hazard analysis DFMEA and test planning in alignmentwith QMS processes.

• Support post-market design changes by drivingand reviewingECNs root cause analysis risk reassessment and associated verification/validation and documentation updates.

• Serve as a hands-onQMS Compliance leaderwithin cross-functional teams influencing execution throughexpertise collaboration and clear decision-making in a matrixed environment.

• Review supplier qualifications process validations and manufacturing documentation from OEMs to ensure compliance with medical device requirements.

• Support internal audits supplier audits and regulatory inspections

Qualifications & Experience

• Bachelors orMasters degree in Engineering(Mechanical Electrical Biomedical) Quality ora relatedtechnical discipline.

• 5 years of experience indesign controls and post-marketsustaining of medical devices

• Strong experience supporting electromechanical medical devices preferably within consumer electronics or high-velocity product development environments.

• Deepexpertisein 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 anddistributors including qualification process validation review and ongoing compliance oversight.

• Working knowledge of biocompatibility electrical safety labeling andcomponentchange impact assessments.

• Strong communicationskills and the ability tooperateeffectively in a complex matrixed organization.

• Pragmatic detail-oriented mindset suited to fast-pacedinnovative-driven environments.