Senior Product Safety and Compliance Engineer- Medical Devices
Leads medical device regulatory compliance and certification for consumer products, ensuring adherence to FDA, EU MDR, and ISO standards while managing risk and product safety from concept to market.
Compensation
$92.2K–$141.4K / yr
Location
Needham, MA, United States
Work setup
Not specified
Seniority
Senior
Employment
Not specified
Experience
5+ years
Category
Industrial engineering
Posted
Skills
ai
embedded-systems
hazard-identification
iso-13485
regulatory-compliance
Must have
Bachelor’s degree in engineering (Electrical, Mechanical, Biomedical, Systems, Materials, or a related engineering discipline); RAC certification a plus. An engineering degree is a firm requirement fo
Hands-on experience on the design side of both product design and certification: you have taken electromechanical products through agency evaluation and regulatory submission from concept to productio
Minimum 5+ years of compliance or design experience with consumer, commercial, or medical electromechanical products.
Strong working knowledge of medical device regulatory standards, including: IEC 60601-1 and applicable collateral/particular standards (esp. IEC 60601-1-2 EMC, IEC 60601-1-6 usability, IEC 60601-1-11
Experience with DFMEA and medical-grade risk management documentation (hazard analysis, risk control verification, residual risk justification).
A strong cross-functional communicator: you build working relationships across Engineering, Quality, Industrial Design, Supply Chain, and Marketing, and present complex regulatory information confiden
Well-organized and detail-driven: you produce submission-quality documentation and keep traceable records across concurrent workstreams without letting submission status, design-change impacts, or age
Strong at managing time and resources: you sequence certification work against program gates, use lab and sample capacity efficiently, and flag schedule risk before it becomes a program delay.
Self-driven and adaptable: you operate with moderate supervision, set priorities across concurrent programs, and thrive in a fast-paced environment with shifting priorities and evolving regulatory gui
Principled under pressure: you hold firm on safety and compliance positions when program timelines are tight, and you collaborate and find workable paths forward where the standards allow — without co
A problem-solver: you offer technically sound solutions to complex problems including ambiguous regulatory pathway questions — using benefit-risk trade-offs under ISO 14971.
An owner: you want the ball — and the “last shot of the game” mentality to go with it.
Nice to have
Experience interfacing directly with FDA, Notified Bodies, or accredited test laboratories.
Familiarity with international medical device regulations for key markets (Health Canada, TGA Australia, ANVISA Brazil).
Discipline-specific depth: Biomedical (ISO 10993, clinical evaluation), Systems (ISO 14971, design controls), Materials (REACH/RoHS, biocompatibility), or Software (IEC 62304, embedded systems complia
Full description
About Us
SharkNinja is a global product design and technology company, with a diversified portfolio of 5-star rated lifestyle solutions that positively impact people’s lives in homes around the world. Powered by two trusted, global brands, Shark and Ninja, the company has a proven track record of bringing disruptive innovation to market and developing one consumer product after another has allowed SharkNinja to enter multiple product categories, driving significant growth and market share gains. Headquartered in Needham, Massachusetts with more than 4,100 associates, the company’s products are sold at key retailers, online and offline, and through distributors around the world.
AI at SharkNinja
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.
Senior Product Safety & Compliance Engineer – Medical Devices
NPD Compliance – Medical Devices & Consumer Products
The Senior Product Safety & Compliance Engineer partners directly with global product development teams and certification partners on all aspects of regulatory compliance and product certification. This is a senior, high-ownership role: you will lead multiple certification projects from product concept to mass production, ensure all market access requirements are met, and drive product designs to incorporate appropriate risk mitigation. The role spans FDA-regulated medical devices and products subject to EU MDR 2017/745 alongside our consumer and commercial portfolio and includes mentoring junior engineers.
What You'll Do
Own certification activities and risk analysis for multiple new product development projects, including FDA-regulated medical devices and products subject to EU MDR 2017/745.
Lead preparation of regulatory filings — FDA 510(k) submissions and Technical Files/Design Dossiers — and maintain Design History Files (DHF) in compliance with 21 CFR Part 820 Design Controls and ISO 13485.
Partner day-to-day with Engineering, Quality, Industrial Design, Supply Chain, and Marketing to align regulatory strategy with program goals, translating complex requirements into actionable guidance for design engineers and product managers.
Own certification timelines, test lab capacity, sample plans and builds, and certification budgets across simultaneous consumer and regulated-device programs, escalating resource conflicts early.
Establish project needs and deliverables for product development teams and third-party partners, including Notified Bodies and FDA-accredited testing laboratories.
Senior Product Safety and Compliance Engineer- Medical Devices at SharkNinja (Needham, MA, United States) — aijobsearch
Execute risk management per ISO 14971 — hazard identification, risk estimation and evaluation, and residual risk documentation across the product lifecycle.
Drive usability engineering per IEC 62366-1, including formative and summative evaluation planning for devices intended for home healthcare environments.
Lead weekly project reviews with decision-ready materials covering status, certification timelines, and Notified Body or FDA feedback cycles.
Serve as subject matter expert on biocompatibility (ISO 10993), software lifecycle (IEC 62304), and home healthcare electrical safety (IEC 60601-1-11), and lead post-market surveillance and complaint handling under 21 CFR Part 803 and EU MDR.
Mentor junior team members on consumer product certification and medical device regulatory frameworks.
Required Qualifications
Bachelor’s degree in engineering (Electrical, Mechanical, Biomedical, Systems, Materials, or a related engineering discipline); RAC certification a plus. An engineering degree is a firm requirement for this role.
Hands-on experience on the design side of both product design and certification: you have taken electromechanical products through agency evaluation and regulatory submission from concept to production — not solely in documentation, auditing, or quality-records roles.
Minimum 5+ years of compliance or design experience with consumer, commercial, or medical electromechanical products.
Strong working knowledge of medical device regulatory standards, including:
IEC 60601-1 and applicable collateral/particular standards (esp. IEC 60601-1-2 EMC, IEC 60601-1-6 usability, IEC 60601-1-11 home healthcare environments)
ISO 14971 – Risk Management; ISO 13485 – Quality Management Systems
EU MDR 2017/745 – classification rules, Technical Documentation, and UDI obligations
FDA 510(k) submission processes
Experience with DFMEA and medical-grade risk management documentation (hazard analysis, risk control verification, residual risk justification).
Preferred
Experience interfacing directly with FDA, Notified Bodies, or accredited test laboratories.
Familiarity with international medical device regulations for key markets (Health Canada, TGA Australia, ANVISA Brazil).
Discipline-specific depth: Biomedical (ISO 10993, clinical evaluation), Systems (ISO 14971, design controls), Materials (REACH/RoHS, biocompatibility), or Software (IEC 62304, embedded systems compliance).
Who You Are
A strong cross-functional communicator: you build working relationships across Engineering, Quality, Industrial Design, Supply Chain, and Marketing, and present complex regulatory information confidently at all levels.
Well-organized and detail-driven: you produce submission-quality documentation and keep traceable records across concurrent workstreams without letting submission status, design-change impacts, or agency action items slip.
Strong at managing time and resources: you sequence certification work against program gates, use lab and sample capacity efficiently, and flag schedule risk before it becomes a program delay.
Self-driven and adaptable: you operate with moderate supervision, set priorities across concurrent programs, and thrive in a fast-paced environment with shifting priorities and evolving regulatory guidance.
Principled under pressure: you hold firm on safety and compliance positions when program timelines are tight, and you collaborate and find workable paths forward where the standards allow — without compromising on safety.
A problem-solver: you offer technically sound solutions to complex problems including ambiguous regulatory pathway questions — using benefit-risk trade-offs under ISO 14971.
An owner: you want the ball — and the “last shot of the game” mentality to go with it.
Salary and Other Compensation: 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.
The Company offers the following benefits for this position, subject to applicable eligibility requirements: 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
$92,200—$141,400 USD
Our Culture
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.
What We Offer
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. Together, 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.
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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