Senior Medical Device Regulatory & Certification Engineer

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

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.