Base: $124,800 to $159,600 py; bonus/equity: not s...
Hybrid
Reliability studies and evaluations
Complaint and product failure investigations
Design verification and validation
This role supports engineering functions within new product development for complex electro-mechanical and electronic medical devices, focusing on achieving required product reliability
Job Summary
This role supports engineering functions within new product development for complex electro-mechanical and electronic medical devices, focusing on achieving required product reliability.
The position requires navigating various government and industry regulations including FDA 21 CFR part 820 and ISO standards, and involves coordinating complaint and product failure investigations.
Employees receive benefits including incentive plans, 401(k) with employer match, paid time off, employee stock purchase plan, and more, with a hybrid work model onsite in Lafayette, CO four days per week.
Matching Summary
This role supports engineering functions within new product development for complex electro-mechanical and electronic medical devices, focusing on achieving required product reliability.
Salary
Base: $124,800 to $159,600 per year; Bonus/Equity: Not specified; Benefits: Incentive plans, 401(k) with employer contribution and match, paid time off, employee stock purchase plan, and more
Skills & Requirements
Must-have
Reliability studies and evaluations
Complaint and Product Failure Investigations
Design Verification and Validation
Statistical tools and Reliasoft software
Physics of Failure reliability models
Accelerated life testing (ALT and HALT)
Use of nCode and NASTRAN software
Nice-to-have
Medical Device Risk Management
Compliance with IEC and FDA standards
Human Factor Engineering
Root cause analysis and CAPA coordination
Hybrid onsite work model
Key Requirements
Master’s degree in Mechanical, Electrical or Biomedical Engineering with 2 years experience or Bachelor’s degree with 5 years experience
At least 2 years experience in reliability or quality engineering roles
Experience with DOE constructs and reliability studies
Experience with complaint investigations and CAPA
Experience with design control deliverables and human factors engineering
Experience using Reliasoft, nCode, and NASTRAN software