Job SummaryThe Senior Manufacturing Engineer develops, implements and sustains manufacturing processes, equipment, tooling, fixtures and technical methods used to produce medical-device components and assemblies.
The role provides hands-on production support, leads technical investigations and improvements, and owns the technical manufacturing solution for assigned processes, including methods, parameters, operating windows, equipment and tooling requirements, cycle-time requirements and technical documentation. The position works cross-functionally to ensure safe, capable, efficient and compliant manufacturing.
Role and ResponsibilitiesManufacturing Process, Equipment and Improvement- Provide day-to-day engineering support and troubleshoot issues affecting quality, yield, throughput, equipment performance, safety or delivery, working with Operations, Quality and Maintenance to contain problems and implement corrective actions.
- Develop and maintain manufacturing methods, process parameters, operating limits, equipment, tooling and fixture requirements.
- Conduct engineering studies and experiments, analyze process capability and lead improvements in quality, scrap, cycle time, throughput and process stability.
- Develop technical specifications, evaluate supplier proposals and support equipment and tooling acceptance, installation, startup, qualification and release to production.
- Resolve equipment-related issues, improve existing processes and evaluate new manufacturing technologies to increase capability, reliability, safety and productivity.
Root-Cause Analysis- Lead or participate in structured investigations using methods such as 8D, 5 Whys, cause-and-effect analysis and designed experiments; analyze process data, equipment performance, inspection results and manufacturing history to identify and verify root causes.
- Develop technical recommendations, support corrective-action implementation and effectiveness verification, and document investigation evidence, conclusions and improvements.
New-Product Introduction and Production Transfer- Support feasibility reviews, manufacturing-risk assessments, process planning and evaluation of product and process manufacturability.
- Develop the technical manufacturing solution for assigned processes, including required equipment, tooling, fixtures, materials, utilities, controls and process parameters.
- Support prototype, pilot and preproduction builds and transfer stable, capable and documented processes to Operations.
Documentation, Validation and Quality Support- Develop and maintain work instructions, setup and process-parameter documentation, and engineering-study, process-development and capability reports.
- Provide technical input to PFMEAs, control plans, risk assessments and validation protocols.
- Support equipment qualification and process validation, including IQ, OQ and PQ, as well as change controls, nonconformance investigations and CAPA activities.
- Ensure engineering activities comply with applicable procedures and quality-system requirements and collaborate effectively with Operations, Quality, NPI, Maintenance, Automation Engineering, Supply Chain and suppliers.
Qualifications- Experience with manufacturing-process and equipment troubleshooting, process development, engineering studies, process capability, statistical analysis, structured problem-solving, equipment qualification or process validation preferred.
- Lean manufacturing, Six Sigma or continuous-improvement experience preferred.
- Additional preferred experience: laser cutting, welding or marking; precision grinding; Swiss machining; EDM; electrochemical machining; electropolishing; cleaning, passivation or deburring; tooling and fixture design; and small-diameter tube or wire manufacturing.
Education and ExperienceA bachelor's degree in mechanical engineering, manufacturing engineering, industrial engineering or a related technical discipline is required. Three or more years of manufacturing-engineering, process-engineering or related technical experience, including production support in a regulated environment, is preferred, with medical-device experience strongly preferred.
Physical Requirements- Frequent performing repetitive work
- Occasional lifting (max. 40 lbs.)
- Occasional carrying (max. 40 lbs.)
- Subject to physical hazards from moving equipment and machine parts
- Constant safety glasses
- Constant full PPE
- Frequent standing
- Occasional sitting, walking, pushing, pulling, reaching
- Ability to work in office and manufacturing environments, use a computer for extended periods, and observe equipment operation and manufacturing trials
- Occasional travel to suppliers, customers or other company facilities may be required
- Regular attendance in the office is required
What We Offer:- On-the-job training and advancement opportunities
- Competitive wages
- Great benefits like health, dental, vision, life, and disability insurance; 401K and much more.
- Paid time off, sick time and holiday pay
- Employee Assistance Program/ Tuition Reimbursement
Monday to Friday, Standard Working Hours
