Manufacturing Process Engineer

Job Title: Manufacturing Process Engineer (Medical Devices)

Location: Nashua, NH (NPI Center) – 100% Onsite

Duration: 12 Months + Possible Extension

Job Overview

We are seeking an experienced Manufacturing Process Engineer to support New Product Introduction (NPI) activities within a medical device environment. This role focuses on developing and optimizing manufacturing processes, creating detailed assembly work instructions, and supporting process risk management activities. The ideal candidate will have strong hands-on aptitude with electromechanical systems and the ability to translate design concepts into robust manufacturing processes.

Key Responsibilities

• Develop, document, and optimize manufacturing processes for new and existing medical device products
• Create and maintain assembly work instructions, ensuring clarity, accuracy, and compliance with internal standards
• Perform process risk assessments, including creation and maintenance of PFMEA
• Support New Product Introduction (NPI) activities, including design transfer to manufacturing
• Collaborate with cross-functional teams including R&D, Quality, and Manufacturing
• Analyze and improve manufacturing workflows for efficiency and quality
• Perform hands-on evaluation, including disassembly and reassembly of electromechanical systems to understand product functionality
• Ensure compliance with applicable regulatory and quality standards

Required Qualifications

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or related field
• 10+ years of experience in medical device manufacturing and/or product development
• Experience working with electromechanical systems in a hands-on environment
• Strong understanding of process risk management, including PFMEA
• Experience creating assembly work instructions with high attention to detail
• Ability to interpret technical requirements and translate them into manufacturing processes
• Familiarity with SolidWorks (viewer level; basic CAD exposure preferred)

Preferred Skills

• Experience in New Product Introduction (NPI) environments
• Exposure to design transfer and manufacturing readiness activities
• Strong technical writing and documentation skills
• Detail-oriented with strong problem-solving abilities
• Ability to work independently and in cross-functional teams

Ideal Candidate Profile

• Hands-on, curious, and mechanically inclined
• Strong in process development + documentation
• Comfortable working in a fast-paced NPI environment
• Able to bridge the gap between design and manufacturing