Senior Medical Device Safety & Regulatory Engineer

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

Benefits offered by this job

Health insurance

401(k) with matching

Generous paid time off

Employee stock purchase program

Job summary

Ninjakitchen is seeking a Senior Product Safety & Compliance Engineer to oversee regulatory compliance and project certifications for their innovative products. The role requires collaboration with global teams to ensure safety and effectiveness in market-ready products.

Ideal candidates will have a bachelor's degree in engineering and over 5 years of experience in medical device regulations, capable of leading projects through complex compliance landscapes while mentoring junior colleagues.

Qualifications

• Minimum 5+ years of compliance or design-related experience.
• Strong working knowledge of medical device regulatory standards.
• Experience interfacing with FDA or Notified Bodies.

Responsibilities

• Lead certification activities and risk analysis for product development.
• Prepare and maintain regulatory filings and design history files.
• Evaluate project risks and establish contingency plans.

Skills

Medical device regulatory knowledge

Risk management

Project management

Usability engineering

Education

Bachelor's degree in Engineering or related field

Tools

FDA submission processes

ISO standards (13485, 14971)

Job description

Ninjakitchen is seeking a Senior Product Safety & Compliance Engineer to oversee regulatory compliance and project certifications for their innovative products. The role requires collaboration with global teams to ensure safety and effectiveness in market-ready products.

Ideal candidates will have a bachelor's degree in engineering and over 5 years of experience in medical device regulations, capable of leading projects through complex compliance landscapes while mentoring junior colleagues.