NPI Manufacturing Engineer

Job Title: NPI Manufacturing Engineer – Pharma/Medical Device Location: Andover, MA (100% Onsite) Schedule: Monday to Friday, 8:00 AM – 5:00 PM

Job Summary:

We are seeking a highly skilled NPI Manufacturing Engineer to support the development and manufacturing of innovative pharmaceutical and medical device products. This role is instrumental in defining and developing manufacturing processes, driving product quality, and ensuring compliance with FDA and ISO regulations.

Key Responsibilities:

Lead PFMEA (Process Failure Mode and Effects Analysis) activities in collaboration with cross-functional teams (Product Development, Quality, and Manufacturing Engineering).

Participate in Design for Manufacturability (DFM) and Design for Assembly (DFA) efforts to optimize product design for efficient and reliable production.

Develop robust assembly and testing methods to meet all Critical to Quality (CTQ) requirements.

Support new product introductions (NPI) and enhancements, focusing on process development for both disposables and capital equipment.

Execute and document Test Method Validation (TMV) and Verification & Validation (V&V) activities.

Requirements

• Bachelor’s Degree in Engineering or related field (required).

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

• Proven background in NPI Manufacturing and/or Process Development , including experience with disposables and capital equipment .

• Strong knowledge and hands-on experience in TMV , V&V , and quality documentation practices.