More jobs:
Mechanical Engineer; EU MDR
Job in
Aurora, Arapahoe County, Colorado, 80012, USA
Listed on 2026-09-12
Listing for:
Actalent
Full Time
position Listed on 2026-09-12
Job specializations:
-
Engineering
Medical Device Industry
Job Description & How to Apply Below
Lead the design, development, and compliance strategy for medical devices to ensure alignment with EU MDR 2017/745 regulations. This includes generating technical documentation, performing risk assessments, and coordinating with Notified Bodies for audits.
Requirements:Requires a degree in Mechanical, Biomedical, or Electrical Engineering with several years of R&D experience in the medical device industry. Candidates must have demonstrated expertise in EU MDR technical documentation and design controls.
KeySkills:
- EU MDR 2017/745
- Design Controls
- Technical Documentation
- Risk Management
- FMEA
- Verification and Validation
- Solid Works
- Windchill
- ISO 14971
- 21 CFR 820.30
- CAPA
- Notified Body Audits
- Technical File Maintenance
- GSPR Compliance
- Clinical Evaluation
- Post-Market Surveillance
- Medical
- Dental
- Vision
- Critical Illness
- Accident
- Hospital
- 401(k) Retirement Plan
- Life Insurance
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Paid Time Off
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