Mechanical Engineer (EU MDR)

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

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.

Key Skills:

• EU MDR 2017/745
• Design Controls
• Technical Documentation
• Risk Management
• FMEA
• Verification and Validation
• SolidWorks
• Windchill
• ISO 14971
• 21 CFR 820.30
• CAPA
• Notified Body Audits
• Technical File Maintenance
• GSPR Compliance
• Clinical Evaluation
• Post-Market Surveillance

Benefits:

• 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