Sr Reliability Engineer
Job in
Minneapolis, Anoka County, Minnesota, 55432, USA
Listed on 2026-06-02
Listing for:
Artech LLC
Full Time
position Listed on 2026-06-02
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer, Medical Device Industry, Systems Engineer
Job Description & How to Apply Below
Job Title:
Sr Reliability Engineer
Job
Location:
7000 Central Ave NE Minneapolis Minnesota 55432
Duration: 12 months
Pay Range: $55.00 - $60.00/HR. on W2
Role Overview
Sr. Risk Engineer responsible for driving and maintaining medical device risk management activities across Class III products. Focus is on ISO 14971 compliance, design controls, and cross-functional risk collaboration throughout the product lifecycle.
Key Responsibilities- Maintain and update Risk Management Files for medical devices
- Perform hazard analysis, FMEA, risk evaluation, and mitigation tracking
- Ensure risk controls are implemented, verified, and validated
- Collaborate with Design, Human Factors, Reliability, Safety, and Post-Market teams
- Assess and document patient safety and product performance risks
- Support design control deliverables (DV/PV, usability, design transfer, specs)
- Drive risk process consistency and continuous improvement across projects
- Communicate risk findings to leadership and stakeholders
- 3+ years ISO 14971 experience in medical devices
- Experience maintaining risk management files (Class III preferred)
- Strong knowledge of design controls / quality design deliverables
- Experience with hazard analysis, FMEA, risk assessment
- Implantable or complex medical devices
- FDA 21 CFR 820, ISO 13485, EU MDR knowledge
- Statistics / risk quantification methods
- Human factors / usability engineering exposure
- Strong cross-functional collaboration & consensus building
- Attention to detail and documentation accuracy
- Ability to evaluate and communicate patient risk impacts
- Leadership in risk discussions and decision-making support
Ensuring medical devices are safe, compliant, and risk-controlled throughout design and development by managing ISO 14971-based risk files and working closely with engineering and quality teams.
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