Senior Process Engineer

M-F / ONSITE

Core hours between 6-8am EST start and 3-5pm EST end with potential for 1-2 hours of overtime per week.

This role would spend much of the day supporting process validation activities by running samples on manufacturing equipment, collecting and analyzing data, and documenting results in validation reports. They would work closely with Quality, Operations, and Engineering teams to ensure processes meet requirements. In addition, they would help set up components, fixtures, tooling, and equipment on the assembly line, troubleshoot issues during builds, and support process improvements as products move into production. Assist and collaborate with materials team to make sure the line is set up to receive components/raw materials. Overall, the position combines hands-on manufacturing support with technical documentation and cross-functional collaboration

The role contributes to the delivery of high impact, cost transformative projects. The role will require the successful candidate to operate across a network of stakeholders from Product Transfer, Operations and Divisional partners, therefore strong interpersonal skills and communication skills will be necessary. Position will require PPAP skills, analyze equipment to establish operating data, conduct experimental test and result analysis. May lead or act as independent reviewer in process review meetings. Participate in PFMEA, Control Plan, SOP, PPAP and other company internal process qualification generation associated with product transfers.

Ensure adherence to GMP and safety procedures.
Equipment Validation Experience.
Statistical methods for process development.
Manufacturing/Test Equipment Integration & Troubleshooting

PPAP experience, ability to manage a workstream and its tasks, Complex problem solving,Six Sigma/continuous improvement

Engineering degree, 4 years experience
Medical industry experience STRONGLY preferred