Release Train Engineer
The Hartford
Staff / Senior Staff Advanced Manufacturing Engineer, MedTech
Knowles Precision Devices
full-time
Posted on:
Location: Illinois • 🇺🇸 United States
Visit company websiteSalary
💰 $112,000 - $170,000 per year
Job Level
Senior
About the role
- Lead the development and implementation of manufacturing processes for new medical devices or components
- Own Design for Manufacturability (DFM) and manage design transfer from R&D to production
- Develop and optimize tooling, fixtures, automation strategies, and production workflows
- Support Design Verification & Validation (DV&V) activities, including test method development
- Conduct cost analysis for manufacturing including capital investments and make/buy decisions
- Serve as the technical subject matter expert (SME) on cross-functional project teams
- Collaborate with R&D, Quality, Regulatory, and Operations to ensure product performance and manufacturability
- Engage with customers to communicate process capabilities, validation strategies, and DFM recommendations
- Lead root cause investigations, corrective actions (CAPAs), and implement design or process improvements
- Develop and execute IQ/OQ/PQ protocols for equipment and process validation
- Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable global regulations
- Maintain documentation and traceability in alignment with design controls and quality systems
Requirements
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field. Masters preferred
- 8–10+ years of experience in medical device design, manufacturing, or process engineering
- Strong knowledge of: Medical device regulations (FDA, ISO 13485, EU MDR)
- Strong knowledge of: Validation protocols (IQ/OQ/PQ)
- Strong knowledge of: CAD tools (e.g., SolidWorks, Creo)
- Strong knowledge of: Statistical tools (DOE, Minitab, Six Sigma)
- Preferred: Experience with Class II or III implantable or disposable medical devices
- Preferred: Hands-on expertise with manufacturing processes such as injection molding, laser welding, metal stamping, packaging, or sterilization
- Preferred: Familiarity with design controls and PLM systems (e.g., Agile, Windchill)
- Preferred: Certified Six Sigma Green/Black Belt or Certified Quality Engineer (CQE)
- Strong written and verbal communication skills; capable of authoring technical reports, protocols, and presenting to stakeholders.
