- Contract manufacturing medical device company
- Leadership opportunities
About Our Client
Our Engineering and Manufacturing division recently partnered with a medical device component / contract product manufacturing company located in MA, that partners with a lot of the big names within the medical device industry to design and manufacture products according to their needs.
Develop and oversee the execution of process validations including but not limited to IQs, OQs, PQs, Gage R&Rs, and other engineering studies, qualifications, and/or DOEs.
Develop manufacturing process designs and coordinate with tooling and equipment sources for construction and validation.
Design, source/fabricate and qualify assembly fixtures for product development and production when appropriate.
Lay out, build, test, troubleshoot, repair, and modify developmental and production equipment, and prototype systems, such as control instrumentation and machine tool numerical controls.
Create, review, and maintain documentation required to implement print and customer requirements into documented procedures for operating processes, including but not limited to, manufacturing instructions, setup instructions, routers, and BOMs.
Analyze and plan work force utilization, space requirements, work flow, design layout of equipment and work space for maximum efficiency for existing and new projects while embodying lean
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant
- B.S. in Engineering
- 5-10 years of experience working in manufacturing role in an ISO 13485 work environment
- IQ, OQ, PQ experience
- Project Management experience or background
- Process development experience
- Knowledge and experience with ISO 13485, QSR 21 CFR 820, GMP, and FDA practices and requirements
- Leadership skills
- Excellent communication skills
What's on Offer
- Strong compensation package and benefits (health, dental, vision, 401k, potential bonus's etc)
- Opportunity to grow fast within the company
- Variety of products on a day to day basis
- Close knit team / small to medium size site
- Exposure to a lot of other parts of the business - working with the operations group with builds including the warehouse - more exposure than what you would have in a larger corporation environment
- Work life balance