Job Title: Manufacturing Process Engineer
Location: Nashua, NH
Duration:12 Months
Position Overview:
We are seeking an experienced Manufacturing Process Engineer to support New Product Introduction (NPI) activities at our Nashua, NH facility. This role will focus on developing and optimizing manufacturing processes, supporting assembly operations, and ensuring robust process documentation within a regulated medical device environment.
The ideal candidate will have strong hands-on experience with electromechanical systems, process development, and risk management methodologies.
Key Responsibilities:
- Support NPI activities, including process development and manufacturing readiness
- Develop and maintain assembly work instructions with a high level of detail and accuracy
- Perform hands-on evaluation, including disassembly and reassembly of electromechanical systems
- Collaborate with cross-functional teams including Engineering, Quality, and Manufacturing
- Utilize SolidWorks (or similar CAD tools) for viewing and basic design support
- Develop and maintain Process Failure Mode and Effects Analysis (PFMEA) as part of risk management
- Ensure processes align with quality and regulatory requirements
- Support continuous improvement initiatives to enhance manufacturing efficiency and product quality
Required Qualifications:
- Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or related field
- 10+ years of experience in medical device development and/or manufacturing
- Hands-on experience working with electromechanical systems (assembly, disassembly, troubleshooting)
- Familiarity with SolidWorks or similar CAD tools (viewing required; basic design skills preferred)
- Strong experience in technical writing, particularly assembly work instructions
- Experience with process risk management, including development of PFMEA
Preferred Qualifications:
- Experience supporting New Product Introduction (NPI) projects
- Familiarity with regulated medical device environments and quality systems
- Exposure to process improvement methodologies
