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![Michael Page](https://media.trabajo.org/img/noimg.jpg)
Principal Manufacturing Engineer
1 month ago
The Lead Manufacturing Engineer will be responsible for overseeing and leading projects as a technical individual contributor for one of the most essential medical device products about to hit the market.
Client Details
The small start up is FDA approved and working on bringing a hand held optical medical device product to market for the first time. An organization that presents a product that will hopefully eliminate some challenges throughout the health care industry.
Description
The Lead Manufacturing Engineer will be responsible for:
- Capable of overseeing multiple third-party manufacturers producing various components of medical devices
- Skilled at partnering with external vendors and contract manufacturers to develop, specify, and document production processes, including potential failure modes and associated risks
- Proficient in designing and implementing validation and qualification procedures for sophisticated optical medical devices
- Well-versed in medical device manufacturing regulations
- Possesses practical understanding of design control principles for medical devices
- Experienced in developing manufacturing and process-related protocols, tracking progress, analyzing data, and providing informed suggestions
- Collaborates with R&D, Marketing, Quality, and Manufacturing teams to identify opportunities for improving manufacturing, materials, and products, offering innovative solutions at both system and component levels
- Conducts in-depth design and process assessments, providing feedback or approval on detailed component and equipment specifications
- Able to create or modify facility procedures and instruct staff as needed to implement manufacturing changes
- Knowledgeable about Change Management processes for products, labeling, and packaging
- Applies expertise in general engineering concepts, materials science, risk management, and reliability to meet product requirements
- Designs, constructs, and sources tools and fixtures to support manufacturing needs
Profile
The successful Lead Manufacturing Engineer will have MOST of what follows:
- Holds a bachelor's or master's degree in engineering, preferably specializing in Mechanical or Manufacturing disciplines
- Possesses over 15 years of pertinent experience in the medical device or pharmaceutical sectors, with a strong background in collaborative work environments
- Demonstrates comprehensive understanding of relevant medical device manufacturing standards and regulations (including but not limited to 21 CFR 820, cGMP, ISO-13485)
- Has experience in supporting or producing limited-quantity optical-mechanical devices
- Familiar with the production or support of low-volume sterile single-use items
- Knowledgeable about Class III Medical Devices
- Previous involvement with endoscope, imaging, or machine vision technologies
- Proficient in working with plastics, injection molding techniques, and assembly of miniature components
- Holds training or certification in process/operations excellence methodologies (such as Six Sigma, Lean, Green Belt, or Black Belt)
Job Offer
The successful Lead Manufacturing Engineer will be offered:
- Start up medical device company
- Great offer package with full benefits and company equity
- Lead position with incredible growth opportunity
- Truly a position that you can make your own
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.
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