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Principal Manufacturing Engineer

2 months ago

Natick, United States Michael Page Full time

  • Incredible growth opportunity with an FDA approved product launch
  • A unique device the market has never seen before

    About Our Client

    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.

    Job 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 devicesWell-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 suggestionsCollaborates 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 levelsConducts in-depth design and process assessments, providing feedback or approval on detailed component and equipment specificationsAble to create or modify facility procedures and instruct staff as needed to implement manufacturing changesKnowledgeable about Change Management processes for products, labeling, and packagingApplies expertise in general engineering concepts, materials science, risk management, and reliability to meet product requirementsDesigns, constructs, and sources tools and fixtures to support manufacturing needs

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

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 disciplinesPossesses over 15 years of pertinent experience in the medical device or pharmaceutical sectors, with a strong background in collaborative work environmentsDemonstrates 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 devicesFamiliar with the production or support of low-volume sterile single-use itemsKnowledgeable about Class III Medical DevicesPrevious involvement with endoscope, imaging, or machine vision technologiesProficient in working with plastics, injection molding techniques, and assembly of miniature componentsHolds training or certification in process/operations excellence methodologies (such as Six Sigma, Lean, Green Belt, or Black Belt)

What's on Offer

The successful Lead Manufacturing Engineer will be offered:

Start up medical device companyGreat offer package with full benefits and company equity Lead position with incredible growth opportunity Truly a position that you can make your own