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.