Senior Product Safety and Compliance Engineer- Medical Devices

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.The Senior Product Safety & Compliance Engineer will have a direct partnership with our global product developers and certification partners for all aspects of regulatory compliance and product certification. The candidate will be responsible for leading multiple certification projects from product concept to mass production, ensuring that all market access requirements are met and that product designs employ appropriate risk mitigation solutions. This role includes active participation in medical device regulatory pathways alongside our consumer and commercial product portfolio.Here are some of the EXCITING things you'll get to do:Assist in owning the execution of certification activities and risk analysis for multiple new product development projects, including FDA-regulated medical devices and products subject to EU MDR 2017/745.Support the preparation of regulatory filings including 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 requirements.Establish project needs and deliverables for both our product development teams and third-party regulatory partners, including Notified Bodies and FDA-accredited testing laboratories.Execute risk management activities in accordance with ISO 14971, including hazard identification, risk estimation, risk evaluation, and residual risk documentation across the product lifecycle.Support usability engineering processes per IEC 62366-1, including participation in formative and summative evaluation planning for medical device products intended for home healthcare environments.Continuously evaluate project risk during the development process and establish contingency plans to overcome obstacles, including regulatory strategy adjustments driven by classification questions or design changes.Lead weekly reviews for all assigned projects, presenting status and associated project risks including certification timelines and Notified Body or FDA feedback cycles.Assure that all activities related to product certification commence and execute as planned and on schedule, with attention to FDA review timelines and CE marking milestones under EU MDR.Support product development teams as a subject matter expert, providing counsel on medical device-specific requirements including biocompatibility (ISO 10993 series), software lifecycle (IEC 62304), and home healthcare electrical safety (IEC 60601-1-11).Assist in leading intradepartmental continuous improvement and special projects, including contribution to post-market surveillance and complaint handling processes under 21 CFR Part 803 and EU MDR.Provide leadership and mentoring to junior team members on both consumer product certification and medical device regulatory frameworks.Attributes & SkillsBachelor's degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Systems Engineering, Materials Engineering, Computer Science, or a related technical discipline; RAC certification a plus.Relevant discipline context: Biomedical/Bioengineering backgrounds are well-suited to ISO 10993 biocompatibility and clinical evaluation; Systems Engineering to ISO 14971 risk management and design controls; Chemical/Materials Engineering to material selection, substance compliance (REACH, RoHS), and biocompatibility testing; Computer Science/Software Engineering to IEC 62304 software lifecycle and embedded systems compliance.Minimum 5+ years of compliance or design-related 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 for EMC, IEC 60601-1-6 for usability, IEC 60601-1-11 for home healthcare environments)ISO 14971 – Risk Management for Medical DevicesISO 13485 – Quality Management SystemsIEC 62366-1 – Usability EngineeringIEC 62304 – Medical Device Software Lifecycle (where applicable)ISO 10993 series – Biocompatibility Evaluation21 CFR Part 820 – FDA Quality System RegulationEU MDR 2017/745 – classification rules, Technical Documentation, and UDI obligationsFDA 510(k) submission processesFamiliarity with international medical device regulations for key markets (Health Canada, TGA Australia, ANVISA Brazil) preferred.Experience with DFMEA and medical-grade risk management documentation (hazard analysis, risk control verification, residual risk justification).Experience interfacing with FDA, Notified Bodies, or accredited test laboratories preferred.Must be able to:Operate comfortably in a fast-paced environment with regularly shifting priorities, including simultaneous consumer and regulated-device program timelines.Thrive under pressure and want to be continuously challenged.Manage multiple projects simultaneously while maintaining continuous track of key details, including regulatory submission status and design change impact assessments.Multi-task, maintaining a continuous comprehensive understanding of project status across consumer certification and medical device regulatory workstreams.Present creative and technically sound solutions to complex problems, including regulatory pathway questions where classification is ambiguous.Like to "solve the puzzles" and deliver on challenging assignments.Analyze operations and promote continuous improvement initiatives within a design control and post-market surveillance framework.Work with conviction and demonstrate strength on key positions while collaborating and compromising where appropriate.Work and think independently with moderate supervision and generate ideas within their area of expertise.Make sound decisions utilizing all available information, including benefit-risk trade-offs required under ISO 14971.Communicate complex technical and regulatory information to audiences with varying technical understanding.Adapt well to change, including evolving regulatory guidance and new product category entries into regulated spaces.Present at a high level to all levels within the organization, demonstrating comfort and confidence in collaborating with colleagues and superiors.Desire ownership and possess a "want to take the last shot of the game" mentality.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 USDOur CultureAt 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 OfferWe 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. Learn more about us: Life At SharkNinjaOutrageously Extraordinary SharkNinja Candidate Privacy NoticeFor 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 View email address on click.appcast.io