Senior Medical Device Compliance Engineer
Sharkninjaoperatingllc
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Benefits offered by this job
Job summary
SharkNinja is seeking a Senior Medical Device Compliance Engineer in Needham, MA to lead design controls and post‑market compliance across medical devices. This hands‑on role collaborates with Engineering, Legal, Program Management and Quality to ensure safe, compliant products while accelerating development.
You will apply risk management, perform DFMEA, and coordinate ECNs with overseas manufacturers, contributing to fast, high‑velocity product delivery in consumer electronics.
Qualifications
- Bachelor’s or Master’s degree in Engineering or related technical discipline.
- 5+ years designing controls and sustaining medical devices post‑market.
- Experience with electromechanical medical devices in fast‑paced development.
- Deep expertise in design controls and risk management (ISO 14971, hazard analysis, DFMEA).
- Experience with ECNs, root cause analysis, lifecycle risk management.
- Experience with overseas contract manufacturers and distributors.
- Knowledge of biocompatibility, electrical safety, labeling, change impact.
- Strong communication and ability to operate in a matrixed org.
- Pragmatic, detail‑oriented mindset for rapid innovation.
Responsibilities
- Drive design control execution for multiple concurrent NPD programs.
- Lead creation, review, and approval of Design History Files and R&D plans.
- Translate regulatory requirements into actionable product specs.
- Ensure risk management activities align with QMS processes.
- Support post‑market changes through ECNs and verification/validation.
- Act as a hands‑on QMS compliance leader in cross‑functional teams.
- Review supplier qualifications and OEM documentation for compliance.
- Support internal and supplier audits and regulatory inspections.
Skills
Education
Job description
SharkNinjais a global product design and technology company, with a diversified portfolio of 5-star rated lifestyle solutions that positivelyimpactpeople’s 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 than4,100associates, the company’s products are sold at key retailers, online and offline, and through distributors around the world.
At SharkNinja, we’re building an AI-native culture. We’re not waiting for the future; we’re creating it. Our people are expected to experiment boldly, adopt new tools, and continuously raise what’s possible to create meaningful impact for our consumers. If you believe the best way to do your job hasn’t been invented yet, you’ll fit right in.
Needham, MA, United States
The Senior Medical Device Compliance Engineeris responsibleformedicaldevicedesign control, and post-marketcomplianceacrossSharkNinja’sMedical Devices portfolio. This role is hands-on and central to ensuring medical device products aredeveloped andsustainedin compliance with global regulatory requirements—whileoperatingwithin 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 Development,Legal,ProgramManagement, and Quality Engineering, including overseas manufacturing partners.
- 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 management files, verification and validation plans and reports, and traceability, 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, DFMEA, and test planning in alignment with QMS processes.
- Support post-market design changes by driving and reviewing ECNs, root cause analysis, risk reassessment, and associated verification/validation and documentation updates.
- 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.
- 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.
- Bachelor’s or Master’s degree in Engineering (Mechanical, Electrical, Biomedical), Quality, or related technical discipline.
- 5+ years of experience in design controls, and post‑market sustaining of medical devices.
- Strong 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.
- Strong communication skills and the ability to operate effectively in a complex, matrixed organization.
- Pragmatic, detail‑oriented mindset suited to fast‑paced, innovative‑driven environments.
The annual salary range for this position is displayed below. Factors which may affect starting pay within this range may include geography/market, skills, education, experience and other qualifications of the successful candidate.
- medical insurance
- dental insurance
- vision insurance
- flexible spending accounts
- health savings accounts (HSA) with company contribution
- 401(k) retirement plan with matching
- employee stock purchase program
- life insurance
- AD&D
- short‑term disability insurance
- long‑term disability insurance
- generous paid time off
- company holidays
- parental leave
- identity theft protection
- pet insurance
- pre‑paid legal insurance
- back‑up child and eldercare days
- product discounts
- referral bonus program, and more.
Pay Range
$87,800 — $150,000 USD
At SharkNinja, we don’t just raise the bar—we push past it every single day. Our Outrageously Extraordinary mindset drives us to tackle the impossible, push boundaries, and deliver results that others only dream of. If you thrive on breaking out of your swim lane, you’ll be right at home.
We offer competitive health insurance, retirement plans, paid time off, employee stock purchase options, wellness programs, SharkNinja product discounts, and more. We empower your personal and professional growth with high impact Learning Programs featuring bold voices redefining what’s possible. When you join, you’re not just part of a company—you’re part of an outrageously extraordinary community. To gether, we won’t just launch products—we’ll disrupt entire markets.
At SharkNinja, Diversity, Equity, and Inclusion are vital to our global success. Valuing each unique voice and blending all of our diverse skills strengthens SharkNinja’s innovation every day. We support ALL associates in bringing their authentic selves to work, making an impact, and having the opportunity for career acceleration. With help from our leadership, associates, and our community, we aim to have equity be a key component of the SharkNinja DNA.
Learn more about us:
Life At SharkNinja
Outrageously Extraordinary
For candidates based in all regions, please refer to this Candidate Privacy Notice.
For candidates based in China, please refer to this Candidate Privacy Notice.
For candidates based in Vietnam, please refer to this Candidate Privacy Notice.
We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, disability, or any other class protected by legislation, and local law. SharkNinja will consider reasonable accommodations consistent with legislation, and local law. If you require a reasonable accommodation to participate in the job application or interview process, please contact SharkNinja People & Culture at accommodations@sharkninja.com
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