EU MDR Medical Device Design & Compliance Lead

Actalent; Aurora (CO); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

Life Insurance

HSA

Paid Time Off

Job summary

Actalent seeks a lead engineer to drive design, development, and EU MDR 2017/745 compliance for medical devices. You will generate technical documentation, conduct risk assessments, and coordinate Notified Bodies for audits.

The ideal candidate holds a degree in Mechanical, Biomedical, or Electrical Engineering with several years of medical device R&D and strong expertise in EU MDR documentation and design controls.

Qualifications

• Degree in Mechanical, Biomedical, or Electrical Engineering with R&D experience in medical devices.
• Expertise in EU MDR technical documentation and design controls.

Responsibilities

• Lead the design, development, and compliance strategy for medical devices.
• Generate technical documentation, perform risk assessments, and coordinate with Notified Bodies for audits.

Skills

EU MDR 2017/745

Design Controls

Technical Documentation

Risk Management

FMEA

Verification and Validation

ISO 14971

21 CFR 820.30

CAPA

Notified Body Audits

Technical File Maintenance

GSPR Compliance

Clinical Evaluation

Post-Market Surveillance

Education

Bachelor's degree in Mechanical, Biomedical, or Electrical Engineering

Tools

SolidWorks

Windchill

Job description

Actalent seeks a lead engineer to drive design, development, and EU MDR 2017/745 compliance for medical devices. You will generate technical documentation, conduct risk assessments, and coordinate Notified Bodies for audits.

The ideal candidate holds a degree in Mechanical, Biomedical, or Electrical Engineering with several years of medical device R&D and strong expertise in EU MDR documentation and design controls.