Compliance Engineer

<div class="content-intro"><p><strong><span data-contrast="auto">About Us</span></strong><span data-ccp-props="{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:280}">&nbsp;</span></p> <p>SharkNinja&nbsp;is a global product design and technology company, with a diversified portfolio of 5-star rated lifestyle solutions that positively&nbsp;impact&nbsp;people’s lives in homes around the world. <strong>Powered by two trusted, global brands, Shark and Ninja</strong>, the company has a proven&nbsp;track record&nbsp;of bringing disruptive innovation to market and developing one consumer product after another has allowed&nbsp;SharkNinja&nbsp;to enter multiple product categories, driving significant growth and market share gains. Headquartered in Needham, Massachusetts with more than&nbsp;4,100&nbsp;associates, the company’s products are sold at key retailers, online and offline, and through distributors around the world.&nbsp;</p> <p><strong>AI at SharkNinja </strong></p> <p>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.</p></div><p>&nbsp;</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">The Product Compliance Engineer will partner with global product developers and certification partners on regulatory compliance and product certification. The candidate will support certification projects from product concept to mass production, ensuring market access requirements are met and that product designs incorporate appropriate risk mitigation solutions. This role includes participation in medical device regulatory pathways alongside our consumer and commercial product portfolio.</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">Here are some of the EXCITING things you'll get to do:</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· Support 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.</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· Assist in preparing 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.</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· Support the establishment of project needs and deliverables for both product development teams and third-party regulatory partners, including Notified Bodies and FDA-accredited testing laboratories.</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· Execute risk management activities in accordance with ISO 14971, including hazard identification, risk estimation, risk evaluation, and residual risk documentation across the product lifecycle.</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· 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.</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· Evaluate project risk during the development process and support contingency planning to overcome obstacles, including regulatory strategy adjustments driven by classification questions or design changes.</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· Participate in weekly reviews for all assigned projects, presenting status and associated project risks including certification timelines and Notified Body or FDA feedback cycles.</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· 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.</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· 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).</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· Contribute to intradepartmental continuous improvement and special projects, including post-market surveillance and complaint handling processes under 21 CFR Part 803 and EU MDR.</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]"><strong>Attributes &amp; Skills</strong></p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· Bachelor's degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Systems Engineering, Materials Engineering, Computer Science, or a related technical discipline; RAC certification a plus.</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· 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.</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· Minimum 2–4 years of compliance or design-related experience with consumer, commercial, or medical electromechanical products.</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· Working knowledge of medical device regulatory standards including:</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· 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)</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· ISO 14971 – Risk Management for Medical Devices</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· ISO 13485 – Quality Management Systems</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· IEC 62366-1 – Usability Engineering</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· IEC 62304 – Medical Device Software Lifecycle (where applicable)</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· ISO 10993 series – Biocompatibility Evaluation</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· 21 CFR Part 820 – FDA Quality System Regulation</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· EU MDR 2017/745 – classification rules, Technical Documentation, and UDI obligations</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· FDA 510(k) submission processes</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· Familiarity with international medical device regulations for key markets (Health Canada, TGA Australia, ANVISA Brazil) preferred.</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· Experience with DFMEA and medical-grade risk management documentation (hazard analysis, risk control verification, residual risk justification).</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· Exposure to or experience interfacing with FDA, Notified Bodies, or accredited test laboratories preferred.</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]"><strong>Must be able to:</strong></p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· Operate comfortably in a fast-paced environment with regularly shifting priorities, including simultaneous consumer and regulated-device program timelines.</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· Thrive under pressure and want to be continuously challenged.</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· Manage multiple projects simultaneously while maintaining continuous track of key details, including regulatory submission status and design change impact assessments.</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· Multi-task, maintaining a comprehensive understanding of project status across consumer certification and medical device regulatory workstreams.</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· Present creative and technically sound solutions to complex problems, including regulatory pathway questions where classification is ambiguous.</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· Like to "solve the puzzles" and deliver on challenging assignments.</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· Analyze operations and support continuous improvement initiatives within a design control and post-market surveillance framework.</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· Work with conviction while collaborating and compromising where appropriate.</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· Work and think with moderate supervision and generate ideas within their area of expertise.</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· Make sound decisions utilizing all available information, including benefit-risk trade-offs required under ISO 14971.</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· Communicate complex technical and regulatory information to audiences with varying technical understanding.</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· Adapt well to change, including evolving regulatory guidance and new product category entries into regulated spaces.</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· Present confidently to colleagues and leadership across the organization.</p> <p class="font-claude-response-body break-words whitespace-normal leading-[1.7]">· Desire ownership and possess a "want to take the last shot of the game" mentality.</p> <p>&nbsp;</p><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p>&nbsp;</p> <p><span data-teams="true"><strong>Salary and Other Compensation: </strong>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.&nbsp;</span></p> <p><span data-teams="true">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&amp;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.&nbsp;</span></p> <p>&nbsp;</p></div><div class="title">Pay Range</div><div class="pay-range"><span>$72,700</span><span class="divider">&mdash;</span><span>$111,400 USD</span></div></div></div><div class="content-conclusion"><div> <p><strong><span data-contrast="auto">Our Culture</span></strong></p> <p><span data-contrast="auto">At SharkNinja, we don’t just raise the bar—we push past it every single day. &nbsp;</span><strong><span data-contrast="auto">Our Outrageously Extraordinary mindset</span></strong><span data-contrast="auto"> 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.</span></p> <p><strong><span data-contrast="auto">What We Offer</span></strong></p> <p><span data-contrast="auto">We offer competitive health insurance, retirement plans, paid time off, employee stock purchase options, wellness programs, SharkNinja product discounts, and more.&nbsp;</span><strong><span data-contrast="auto">We empower your personal and professional growth </span></strong><span data-contrast="auto">with high impact Learning Programs featuring bold voices redefining what’s possible. </span><strong><span data-contrast="auto">When you join, you’re not just part of a company—you’re part of an outrageously extraordinary community. </span></strong><span data-contrast="auto">To</span><span data-contrast="auto">gether, we won’t just launch products—</span><strong><span data-contrast="auto">we’ll disrupt entire markets.</span></strong><span data-contrast="auto">&nbsp;</span><span data-ccp-props="{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:240}">&nbsp;</span></p> <p><span data-contrast="none">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.</span><span data-ccp-props="{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:240}">&nbsp;</span></p> <p><span data-contrast="none">Learn more about us:</span><span data-contrast="none">&nbsp;</span>&nbsp;<br><a href="https://sharkninja.com/dei"> </a><a href="https://www.instagram.com/sharkninja/"><span data-contrast="none"><span data-ccp-charstyle="Hyperlink">Life At SharkNinja</span></span></a> &nbsp;<br><a href="https://www.youtube.com/playlist?list=PLmRfBxyGu_mKl9SF12lM1NAIx-z07uLNQ"><strong><span data-contrast="none"><span data-ccp-charstyle="Hyperlink">Outrageously Extraordinary</span></span></strong></a><span data-ccp-props="{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:120,&quot;335559739&quot;:120,&quot;335559740&quot;:336}">&nbsp;</span></p> </div> <div> <p data-start="88" data-end="129"><strong data-start="88" data-end="127">SharkNinja Candidate Privacy Notice</strong></p> <ul data-start="131" data-end="402"> <li data-start="131" data-end="224"> <p data-start="133" data-end="224">For candidates based in <strong data-start="157" data-end="172">all regions</strong>, please refer to this <a href="https://www.sharkninja.com/candidate-privacy-notice.html">Candidate Privacy Notice</a>.</p> </li> <li data-start="225" data-end="312"> <p data-start="227" data-end="312">For candidates based in <strong data-start="251" data-end="260">China</strong>, please refer to this <a href="https://www.sharkninja.com/legal/candidate-privacy-notice-china.html">Candidate Privacy Notice</a>.</p> </li> <li data-start="313" data-end="402"> <p data-start="315" data-end="402">For candidates based in <strong data-start="339" data-end="350">Vietnam</strong>, please refer to this <a href="https://www.sharkninja.com/legal/candidate-privacy-notice-vietnam.html">Candidate Privacy Notice</a>.</p> </li> </ul> </div> <div> <p>&nbsp;</p> <p><span style="font-size: 8pt;"><em>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 &amp; Culture at&nbsp;<a href="mailto:accommodations@sharkninja.com">accommodations@sharkninja.com</a></em></span></p> </div></div>