Senior Product Safety and Compliance Engineer- Medical Devices

Senior Product Safety and Compliance Engineer
- Medical Devices

Needham, MA, United States

Shark Ninja 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 Shark Ninja 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.

At Shark Ninja, 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.

• 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.

• Bachelor's degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Systems Engineering, Materials Engineering, Computer Science, or a related technical discipline; RAC…