Senior Manufacturing Engineer

Tegra Medical Holdings LLC•Franklin, MA

11d•$96,000 - $125,000•Onsite

About The Position

The 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.

Requirements

A 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.

Nice To Haves

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.

Responsibilities

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.
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.
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.
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.