Help Bring Innovative Medical Devices from Concept to ProductionAs an Sr. Process Engineer, you will play a key role in developing, optimizing, and scaling manufacturing processes that support the successful launch of new products and serve as the company SME for laser processing.
This is a highly hands-on engineering position that works at the intersection of manufacturing, technology, costing/quoting, and continuous improvement. The ideal candidate brings strong technical knowledge of CNC manufacturing processes-particularly laser cutting, laser welding, and laser marking systems-and enjoys solving complex manufacturing challenges in a regulated environment.
What You'll Do:- Design, develop, validate, and optimize manufacturing processes to support new product introductions and ongoing product improvements.
- Lead process development activities from prototype through commercial production, establishing manufacturing methods, process parameters, and documentation.
- Analyze manufacturing performance and implement improvements that enhance quality, efficiency, throughput, and scalability.
- Apply Lean Manufacturing, continuous improvement, and root cause analysis methodologies to reduce waste, improve productivity, and solve complex manufacturing challenges.
- Develop and maintain process controls that ensure product quality, regulatory compliance, and consistent manufacturing performance.
- Investigate and resolve manufacturing process issues, equipment-related challenges, and process deviations using structured problem-solving and root cause analysis methodologies to identify and implement sustainable corrective actions.
- Support process validation activities, including equipment qualification and production readiness efforts.
- Evaluate and implement manufacturing technologies, equipment, automation, and process enhancements that improve operational performance.
- Support manufacturing cost estimation, quoting, and cost-reduction initiatives through process analysis and optimization.
- Provide hands-on technical support to production teams and lead troubleshooting efforts to improve process stability and reliability.
- Collaborate with Operations, Quality, Supply Chain, Maintenance, and customers to ensure successful product launches and continuous process improvement.
Required Qualifications- Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Engineering Technology, or a related technical discipline; equivalent experience may be considered.
- Hands-on experience with CNC manufacturing equipment. Strong understanding of CNC programming, setup, operation, and process optimization.
- Experience with laser cutting, laser welding, and laser marking systems.
- Experience supporting manufacturing processes in a medical device contract manufacturing (ISO 13485) or other highly regulated manufacturing environment.
- Experience supporting manufacturing cost estimation, quoting, and process costing activities
- Strong analytical, problem-solving, and troubleshooting skills.
- Experience interpreting technical drawings, specifications, and manufacturing documentation.
- Ability to work effectively in a cross-functional team environment.
- Experience performing cycle time studies, capacity analysis, and process improvement initiatives.
- Familiarity with Lean Manufacturing, Six Sigma, and continuous improvement methodologies.
- Knowledge of process validation and statistical process control methodologies.
- Ability to travel, typically between 5% and 25%, depending on project and business needs.
Why You'll Be SuccessfulYou are a hands-on engineer who enjoys working directly with manufacturing equipment and processes. You understand how to optimize production systems, improve efficiency, and solve technical challenges while maintaining the quality standards required in the medical device industry. Whether your background comes from process engineering, manufacturing engineering, CNC operations, or laser systems you bring the curiosity and technical expertise needed to help launch innovative products successfully.
