Senior Manufacturing Engineer

Job Title: Senior Manufacturing Engineer Location: Andover, MA (On-site) Experience: 5+ years

Overview

This role sits at the center of new product introduction, process development, and manufacturing excellence. You’ll work closely with cross-functional teams to build reliable processes, tighten quality controls, and guide products from concept through scalable production.

Responsibilities

• • Lead PFMEA sessions with product development, quality, and manufacturing engineering teams to identify risks early and drive mitigation actions.

• • Contribute to DFM and DFA discussions to shape efficient, cost-effective, and high-quality manufacturing processes for new products and product updates.

• • Develop clear, repeatable assembly and test methods that protect all CTQ requirements throughout the build process.

• • Support design transfer activities and ensure new processes and equipment integrate smoothly into production.

• • Lead Test Method Validation and Verification work, including writing protocols, executing tests, and preparing final reports.

• • Troubleshoot manufacturing issues, refine processes, and provide hands-on support on the production floor.

• • Ensure all process development, documentation, and validation activities follow FDA and ISO quality system standards.

• • Train production teams on new assembly steps, test methods, and equipment as new products move into full-scale manufacturing.

• Required Skills and Qualifications

• • Bachelor’s degree in Engineering or a related field.

• • Medical device background is mandatory.

• • Minimum 5 years of experience in an FDA/ISO regulated medical device or medical equipment manufacturing environment.

• • Proven experience in NPI manufacturing and process development for both disposables and capital equipment.

• • Strong knowledge of Test Method Validation and Verification (TMV, V&V).

• • Solid grounding in PFMEA, DFM, DFA, and CTQ-driven process design.

• • Hands-on experience developing, validating, and optimizing manufacturing processes.

• • Ability to work full-time on-site in Andover MA.