Senior Product Safety and Compliance Engineer- Medical Devices

SharkNinja; Needham (MA); On-site; USD 92,200 - 141,400; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with matching

Paid time off

Job summary

SharkNinja in Needham, Massachusetts, is seeking a Senior Product Safety & Compliance Engineer to manage regulatory compliance and product certification across various product lines, including medical devices.

You will be responsible for certification activities, preparing regulatory filings, leading project reviews, and ensuring compliance with FDA and EU standards. The ideal candidate should have a bachelor's degree in engineering and at least 5 years of experience in compliance.

Qualifications

• 5+ years of compliance or design experience with consumer, commercial, or medical electromechanical products.
• Experience with FDA regulations and medical device standards.

Responsibilities

• Own certification activities and risk analysis for new product development projects.
• Prepare regulatory filings like FDA 510(k) submissions.
• Lead weekly project reviews and present status and risks.

Skills

Compliance experience

Strong knowledge of medical device standards

Risk management documentation

Project management

Education

Bachelor's degree in relevant engineering field

Job description

Job Overview

The Senior Product Safety & Compliance Engineer will partner with global product developers and certification partners to manage regulatory compliance and product certification from concept to mass production. This role supports medical device compliance alongside consumer and commercial product lines.

Responsibilities

• Own certification activities and risk analysis for new product development projects, including FDA‑regulated medical devices and EU MDR 2017/745‑subject products.
• Prepare regulatory filings such as FDA 510(k) submissions and Technical Files/Design Dossiers, and maintain Design History Files in compliance with 21 CFR Part 820 and ISO 13485.
• Coordinate project needs and deliverables with product teams and third‑party partners.
• Execute risk management per ISO 14971, documenting hazards, risk estimation, and residual risk.
• Support usability engineering per IEC 62366‑1, including evaluation planning for home healthcare devices.
• Continuously assess project risk and establish contingency plans for regulatory strategy changes.
• Lead weekly project reviews and present status, risks, and certification timelines.
• Ensure certification activities proceed on schedule with FDA review timelines and CE marking milestones.
• Provide subject‑matter expertise on medical device requirements (e.g., ISO 10993, IEC 62304, IEC 60601‑1‑11).
• Contribute to continuous improvement, post‑market surveillance, and complaint handling under 21 CFR Part 803 and EU MDR.
• Mentor junior team members on certification and regulatory frameworks.

Qualifications

• Bachelor’s degree in Electrical, Mechanical, Biomedical, Systems, Materials Engineering, Computer Science, or related field; RAC certification a plus.
• 5+ years of compliance or design experience with consumer, commercial, or medical electromechanical products.
• Strong knowledge of medical device standards: IEC 60601‑1 (and related), ISO 14971, ISO 13485, IEC 62366‑1, IEC 62304, ISO 10993 series, 21 CFR Part 820, EU MDR 2017/745, FDA 510(k).
• Familiarity with international device regulations (Health Canada, TGA Australia, ANVISA Brazil) preferred.
• Experience with DFMEA, risk management documentation, and interfacing with FDA, Notified Bodies, or accredited labs.

Must Be Able To

• Operate in a fast‑paced environment with shifting priorities.
• Manage multiple projects while tracking regulatory submissions and design change impacts.
• Present solutions to complex regulatory questions.
• Analyze operations and lead continuous improvement initiatives.
• Communicate complex technical information to varied audiences.
• Adapt to regulatory guidance changes and new product categories.

Salary & Benefits

Annual salary range: $92,200—$141,400 USD.

Benefits include medical, dental, vision insurance; flexible spending and health savings accounts; 401(k) with matching; employee stock purchase program; life and disability insurance; paid time off; parental leave; identity theft and pet insurance; legal insurance; child and eldercare days; product discounts; referral bonus program; and more.

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Equal Opportunity Statement

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 or 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 [e-mail].