Principal Manufacturing Engineer

About the Company

A well-established medical device manufacturer is seeking a Senior Manufacturing Engineer to join their team. This is a senior leadership role within a hands-on manufacturing and engineering environment, including ISO Class 7 cleanroom operations. Occasional travel to additional facilities in Gardner, MA and Portland, ME is required.

Position Overview

This role leads design transfer out of R&D and is responsible for developing, implementing, and continuously improving manufacturing capabilities across new and existing product lines. The Senior Manufacturing Engineer serves as a best-practice leader within the product development organization, ensuring that products are optimally designed for manufacturability while driving improvements in productivity, product quality, and cost efficiency.

Key Responsibilities

Manufacturing Process Development

• Lead design transfer activities from R&D into full-scale manufacturing
• Design and develop manufacturing processes, tooling, and fixtures for new products, product changes, and enhancements — targeting zero-defect outcomes and competitive cost structures
• Provide DFM guidance to product development teams covering mechanical assembly, dimensional tolerancing, electrical wiring, materials selection, and fabrication methods
• Perform IQ, OQ, PQ, and Design of Experiments (DOE) activities
• Establish best practices and author manufacturing procedures; develop and maintain Bills of Materials
• Support prototype and pilot production in coordination with R&D, Manufacturing, and Quality Control

Operations & Equipment

• Evaluate capital equipment, generate appropriation justifications, and support procurement decisions
• Oversee preventive maintenance programs for equipment and tooling
• Manage production of consumables and hardware including scheduling, building, testing, packaging, labeling, sterilization coordination, and distribution handoffs
• Coordinate work with outside vendors, technicians, and tool room personnel
• Provide engineering support to production in troubleshooting and resolving technical issues

Documentation & Compliance

• Create and maintain accurate documentation of design concepts, tool drawings, and shop orders in coordination with Quality Assurance and R&D
• Maintain factory GMP compliance in coordination with Document Control, R&D, and Quality Assurance
• Ensure adherence to all applicable regulatory requirements and internal policies including FDA regulations and Good Manufacturing Practices

Team Leadership

• Lead a small team of Manufacturing Engineers
• Train technicians and manufacturing personnel on equipment operation, procedures, and inspection methods
• Provide guidance and mentorship to junior engineering personnel
• Plan and schedule projects in alignment with corporate objectives

Qualifications

Required:

• Bachelor's or Master's degree in Engineering or a related discipline
• 10–15 years of related manufacturing engineering experience
• Demonstrated experience with complex electro-mechanical and/or opto-mechanical products and manufacturing processes; low-to-medium volume production environment preferred
• Experience with Design of Experiments and statistical analysis tools
• Proficiency in Microsoft Word, Excel, Project, and PowerPoint
• Ability to work on complex problems requiring in-depth evaluation of multiple variables and exercise of independent judgment
• US citizenship or US person status required

Preferred:

• Experience with disposable or single-use medical devices
• Six Sigma Black Belt certification

Work Environment & Schedule

• Full-time, onsite position — Monday through Friday
• Work performed in manufacturing, engineering laboratory, and ISO Class 7 cleanroom environments; PPE required in controlled areas
• Occasional travel of 10–15%, including visits to facilities in Gardner, MA and Portland, ME
• Standard use of office equipment; hands-on use of mechanical and electrical manufacturing tools and equipment

Equal Opportunity Statement

This employer is committed to building a diverse and inclusive workplace. All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, or local law.