About this opportunity
KeyPoint Staffing lists this Principal Manufacturing Engineer opportunity in village of nagog woods, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Job Description Job Description 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.
Worksite address
village of nagog woods, MA, 01718, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.