Senior Medical Device Compliance Engineer - Design Controls Lead

Sharkninjaoperatingllc; Needham (MA); On-site; USD 88,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan with matching

Employee stock purchase program

Life insurance

short-term disability insurance

long-term disability insurance

Generous paid time off

Company holidays

Parental leave

Identity theft protection

Pet insurance

Pre‑paid legal insurance

Product discounts

Referral bonus program

Job summary

SharkNinja is seeking a Senior Medical Device Compliance Engineer in Needham, MA to lead design controls and post‑market compliance across medical devices. This hands‑on role collaborates with Engineering, Legal, Program Management and Quality to ensure safe, compliant products while accelerating development.

You will apply risk management, perform DFMEA, and coordinate ECNs with overseas manufacturers, contributing to fast, high‑velocity product delivery in consumer electronics.

Qualifications

• Bachelor’s or Master’s degree in Engineering or related technical discipline.
• 5+ years designing controls and sustaining medical devices post‑market.
• Experience with electromechanical medical devices in fast‑paced development.
• Deep expertise in design controls and risk management (ISO 14971, hazard analysis, DFMEA).
• Experience with ECNs, root cause analysis, lifecycle risk management.
• Experience with overseas contract manufacturers and distributors.
• Knowledge of biocompatibility, electrical safety, labeling, change impact.
• Strong communication and ability to operate in a matrixed org.
• Pragmatic, detail‑oriented mindset for rapid innovation.

Responsibilities

• Drive design control execution for multiple concurrent NPD programs.
• Lead creation, review, and approval of Design History Files and R&D plans.
• Translate regulatory requirements into actionable product specs.
• Ensure risk management activities align with QMS processes.
• Support post‑market changes through ECNs and verification/validation.
• Act as a hands‑on QMS compliance leader in cross‑functional teams.
• Review supplier qualifications and OEM documentation for compliance.
• Support internal and supplier audits and regulatory inspections.

Skills

Design controls

Regulatory compliance

Cross-functional collaboration

Risk management

Root cause analysis

Lifecycle management

Supplier oversight

Biocompatibility knowledge

Electrical safety knowledge

Education

Bachelor’s or Master’s degree in Engineering (Mechanical, Electrical, Biomedical), Quality

Job description

SharkNinja is seeking a Senior Medical Device Compliance Engineer in Needham, MA to lead design controls and post‑market compliance across medical devices. This hands‑on role collaborates with Engineering, Legal, Program Management and Quality to ensure safe, compliant products while accelerating development.

You will apply risk management, perform DFMEA, and coordinate ECNs with overseas manufacturers, contributing to fast, high‑velocity product delivery in consumer electronics.