Principal Test Engineer
$123,200–$184,800 year
On-siteLafayette, Colorado, United States
Job Summary
Design and develop manufacturing processes, procedures, production layouts, and workflows for complex electromechanical medical device assemblies. Lead manufacturing readiness activities for new product introductions, software releases, and design transfer initiatives. Develop and optimize production processes to improve efficiency, quality, throughput, and regulatory compliance while evaluating equipment performance and implementing corrective actions. Collaborate with engineering teams to influence product designs that support manufacturability and incorporate inspection and validation requirements into production plans. Drive statistical process control, Lean Manufacturing, and continuous improvement initiatives to enhance operational performance. Ensure all processes comply with applicable regulatory and quality system requirements. 25% travel required.
Required Qualifications
- Bachelor's degree in Engineering or a related technical discipline
- Minimum of 7 years of relevant manufacturing engineering experience, or an advanced degree with a minimum of 5 years of relevant experience
- Experience developing, implementing, and optimizing manufacturing processes in a regulated industry
- Demonstrated experience leading cross-functional manufacturing projects from concept through implementation
- Strong knowledge of manufacturing systems, process controls, product transfer, and production support activities
- 25% travel required
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
Desired Qualifications
- Experience implementing software releases and test automation solutions within a manufacturing environment
- Experience supporting production software releases and design transfer activities for software-enabled products
- Knowledge of capital equipment manufacturing, including low-volume, high-complexity production environments
- Experience working with motors, sensors, and electromechanical assemblies
- Lean Manufacturing and continuous improvement expertise, including DMAIC methodology and/or Six Sigma Black Belt certification
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