---
title: 'Senior Product Safety and Compliance Engineer- Medical Devices at SharkNinja'
canonical: 'https://feeny.ai/job/senior-product-safety-and-compliance-engineer-medical-devices-sharkninja-0fmdxx0rssw1'
type: 'job'
last_seen: '2026-09-15'
---

# Senior Product Safety and Compliance Engineer- Medical Devices at SharkNinja

- **Company:** SharkNinja
- **Location:** Needham MA, United States
- **Compensation:** $92k–$141k
- **Posted:** 2026-06-01
- **Last confirmed live:** 2026-09-15
- **Apply:** https://job-boards.greenhouse.io/sharkninjaoperatingllc/jobs/4685360006

## Job 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.
- 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
- IEC 62366-1 – Usability Engineering; IEC 62304 – Software Lifecycle (where applicable)
- ISO 10993 series – Biocompatibility Evaluation
- 21 CFR Part 820 – FDA Quality System Regulation
- 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.

Learn more about us: https://sharkninja.com/dei[Life At SharkNinja](https://www.instagram.com/sharkninja/) [Outrageously Extraordinary](https://www.youtube.com/playlist?list=PLmRfBxyGu_mKl9SF12lM1NAIx-z07uLNQ)

SharkNinja Candidate Privacy Notice

- For candidates based in all regions, please refer to this [Candidate Privacy Notice](https://www.sharkninja.com/candidate-privacy-notice.html).

- For candidates based in China, please refer to this [Candidate Privacy Notice](https://www.sharkninja.com/legal/candidate-privacy-notice-china.html).

- For candidates based in Vietnam, please refer to this [Candidate Privacy Notice](https://www.sharkninja.com/legal/candidate-privacy-notice-vietnam.html).

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

## About SharkNinja

## Company Overview
- **One-liner**: SharkNinja is a global product design and technology company that designs, develops, and markets innovative small household appliances under the Shark and Ninja brands.
- **Entity Type**: Public (NYSE: SN)
- **Headquarters**: Needham, Massachusetts, USA
- **Founded**: 2008 (as a merger of Shark and Ninja brands; founding roots go back decades)
- **Founders**: Mark Rosenzweig

## Core Business
- **Primary industries**: Small household appliances (floor care, kitchen, food preparation, beauty, home environment)
- **Target customers**: B2C consumers across all income brackets; sold through major retailers (online and offline) and distributors globally
- **Mission statement**: “To positively impact people’s lives every day in every home in our global markets.”

## Products & Services
- **Shark**: Floorcare products (vacuums, mops, steam cleaners) – #1 floorcare brand in the US by dollar sales.
- **Ninja**: Small kitchen appliances (blenders, food processors, cookers, beverage systems) – best-selling small kitchen appliance brand in the US.
- **Beauty & Home Environment**: Hair care, air purifiers, and other lifestyle appliances (growing category).
- **Product type**: Hardware (consumer electronics/appliances) with integrated software and app connectivity in select products.

## Market Standing
- **Valuation/Market Cap**: Not publicly stated in provided sources; as of 2025 annual report, net sales were $6.4 billion.
- **Key Metric**: Annual Revenue (2025) – $6.4 billion net sales, up ~16% year-over-year. Adjusted EBITDA $1.14 billion (19% growth). Adjusted EPS $5.28 (up 21%).
- **Notable Investors/Partners**: Publicly traded; major institutional investors. Key retail partners include Walmart, Target, Amazon, Costco, and international distributors.
- **Growth Signals**: 21% headcount growth since 2008 (now 4,000+ associates). Expanded into 38 product subcategories. International net sales grew 20.8% in 2025. Strong market share gains across categories.

## Competitive Advantages
- **Continuous disruptive innovation**: Rapid product iteration and refinement based on “always-on” consumer insights and reviews, allowing SharkNinja to solve problems competitors overlook.
- **Scaled engineering powerhouse**: Global cross-functional engineering and product development team that can quickly bring new products to market.
- **Brand trust and market leadership**: Shark is #1 in US floorcare; Ninja is best-selling small kitchen appliance brand. Products have broad appeal across price points, taking share from both higher- and lower-priced competitors.
- **Extensive IP portfolio**: Proprietary technologies and intellectual property that differentiate products and extend product life cycles.

## Strategic Focus
- **Category expansion**: Entering new product categories (beauty, home environment) and subcategories within existing lines.
- **International growth**: Expanding presence in EMEA, Asia, and other global markets (international sales growing faster than domestic).
- **AI and digital transformation**: “Jailbreak” company-wide AI initiative, including AI hackathons and an AI-native early talent program (SharkByte) with a $1M AI Awards prize.
- **Sustainability**: Designing energy-efficient products, reducing carbon footprint across the value chain.

## Why Work Here
- **Culture**: Described as “outrageously extraordinary” – encourages fearless thinking, cross-functional collaboration, and rapid experimentation. Emphasis on innovation and impact.
- **Growth opportunities**: High-impact programs like “Breakthrough Intensive Thinking”, “Built-to-Lead” sessions with executive leadership, and workshops with external voices.
- **AI immersion**: Every employee gets hands-on with AI through Jailbreak initiatives; interns/co-ops in SharkByte program work on real projects with a shot at the $1M AI Awards.
- **Diversity & inclusion**: 14 Employee Resource Groups (ERGs) with executive sponsors, over 500 members worldwide.
- **Community & planet**: Nearly $3.7M donated to nonprofits since 2020; paid volunteer day; matching gifts up to $500/year. Sustainability commitments.
- **Work model**: Not explicitly stated as fully remote; likely hybrid/office-based given headquarters and global offices. Roles span product, engineering, marketing, sales, digital technology, customer excellence, and corporate functions.
- **Locations**: Needham, MA (HQ); offices across America, Europe, and Asia (including UK, China).

## Sources
1. [sharkninja.com](https://www.sharkninja.com/about-us/our-company.html)
2. [careers.sharkninja.com](https://careers.sharkninja.com/)
3. [sec.gov - 2025 Annual Report](https://www.sec.gov/Archives/edgar/data/1957132/000195713226000025/sn-2025arsfinal.pdf)
4. [linkedin.com](https://www.linkedin.com/company/sharkninja)

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