Medical Device Compliance Engineer

Ninjakitchen; Needham (MA); On-site; USD 73,000 - 111,000; Full time

Benefits offered by this job

Medical insurance

401(k) retirement plan with matching

Employee stock purchase program

Job summary

SharkNinja is seeking a Product Compliance Engineer in Needham, MA to drive regulatory approvals for consumer and medical device products. You will partner with global teams on certifications, risk management, and documentation from concept to mass production.

The role requires 2–4 years of compliance experience, knowledge of FDA/EU regulatory pathways, and collaboration with testing labs to ensure market access. This position emphasizes ISO 13485 and software lifecycle standards.

Qualifications

• Bachelor's degree in a technical discipline; RAC a plus.
• Experience with medical device regulatory standards.
• 2–4 years in compliance or design for electromechanical products.

Responsibilities

• Coordinate certification activities for FDA-regulated devices and EU MDR products.
• Prepare regulatory filings, including FDA 510(k) submissions and DHF maintenance.
• Collaborate with Notified Bodies and testing labs to meet timelines.
• Perform risk management per ISO 14971 across product lifecycles.
• Support usability engineering per IEC 62366-1 in home healthcare products.
• Advise on biocompatibility and software lifecycle requirements.

Skills

Regulatory standards

Risk management

Regulatory filings

Usability engineering

Education

Bachelor's degree in Electrical/Mechanical/Biomedical Engineering

Tools

DHF maintenance

FDA 510(k) submissions

Job description

SharkNinja is seeking a Product Compliance Engineer in Needham, MA to drive regulatory approvals for consumer and medical device products. You will partner with global teams on certifications, risk management, and documentation from concept to mass production.

The role requires 2–4 years of compliance experience, knowledge of FDA/EU regulatory pathways, and collaboration with testing labs to ensure market access. This position emphasizes ISO 13485 and software lifecycle standards.