More jobs:
R&D Engineer
Job in
Littleton, Arapahoe County, Colorado, 80161, USA
Listed on 2026-09-12
Listing for:
Actalent
Full Time
position Listed on 2026-09-12
Job specializations:
-
Engineering
Biomedical Engineer, Medical Device Industry, Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
Lead remediation design activities and technical documentation for medical devices to ensure compliance with FDA and ISO standards. Collaborate cross-functionally to execute verification and validation testing and manage product risk assessments.
Requirements:Requires a Bachelor's or Master's degree in Mechanical, Biomedical, or Electrical Engineering with R&D experience in the medical device industry. Must have proven expertise in FDA design controls, risk management tools like FMEA, and proficiency in Solid Works.
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
- Regulatory Compliance
- 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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