R&D Engineer
Job in
Englewood, Arapahoe County, Colorado, 80151, USA
Listed on 2026-09-04
Listing for:
Actalent
Full Time
position Listed on 2026-09-04
Job specializations:
-
Engineering
Biomedical Engineer, Medical Device Industry, Quality Engineering, Systems Engineer
Job Description & How to Apply Below
Lead remediation design activities and technical documentation for medical devices to ensure compliance with FDA design controls. Collaborate with cross-functional teams to execute verification and validation testing and manage product risks through FMEA and fault-tree analysis.
Requirements:Requires a Bachelor's or Master's degree in Mechanical, Biomedical, or Electrical Engineering with professional experience in medical device R&D. Must have a strong understanding of FDA requirements, ISO/IEC standards, and proficiency in Solid Works and PLM systems.
KeySkills:
- FDA Design Controls
- Medical Device Design
- Risk Management
- FMEA
- Verification and Validation
- Technical Writing
- Solid Works
- Windchill
- ISO Standards
- IEC Standards
- CAPA
- Design History Files
- Fault-tree Analysis
- Product Lifecycle Management
- Engineering Studies
- Cross-functional Collaboration
- 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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