Senior Manufacturing Engineering Leader

2 weeks ago

Natick, Massachusetts, United States Michael Page Full time
Exciting Opportunity in Medical Device Manufacturing

Join a dynamic and innovative organization focused on revolutionizing healthcare with a groundbreaking optical medical device. This is a unique chance to be part of a team that is set to launch an FDA-approved product that addresses significant challenges in the industry.

About the Company

This small yet ambitious startup is dedicated to developing a handheld optical medical device that will transform patient care. With FDA approval in hand, the company is poised to make a significant impact in the healthcare sector.

Key Responsibilities

The Senior Manufacturing Engineering Leader will take charge of:
  • Overseeing multiple third-party manufacturers responsible for producing various components of medical devices.
  • Collaborating with external vendors and contract manufacturers to define, document, and refine production processes, while identifying potential failure modes and associated risks.
  • Designing and implementing validation and qualification protocols for advanced optical medical devices.
  • Ensuring compliance with medical device manufacturing regulations.
  • Applying knowledge of design control principles relevant to medical devices.
  • Developing manufacturing and process-related protocols, monitoring progress, analyzing data, and providing informed recommendations.
  • Working closely with R&D, Marketing, Quality, and Manufacturing teams to discover opportunities for enhancing manufacturing processes, materials, and products, offering innovative solutions at both system and component levels.
  • Conducting thorough design and process evaluations, providing feedback or approval on detailed specifications for components and equipment.
  • Creating or modifying facility procedures and guiding staff to implement necessary manufacturing changes.
  • Understanding Change Management processes related to products, labeling, and packaging.
  • Utilizing expertise in engineering concepts, materials science, risk management, and reliability to fulfill product requirements.
  • Designing, constructing, and sourcing tools and fixtures to meet manufacturing needs.
Qualifications

The ideal candidate will possess the following qualifications:
  • A bachelor's or master's degree in engineering, preferably in Mechanical or Manufacturing disciplines.
  • Over 15 years of relevant experience in the medical device or pharmaceutical industries, with a strong emphasis on collaborative work environments.
  • A comprehensive understanding of medical device manufacturing standards and regulations.
  • Experience in supporting or producing limited-quantity optical-mechanical devices.
  • Familiarity with the production or support of low-volume sterile single-use items.
  • Knowledge of Class III Medical Devices.
  • Previous involvement with endoscope, imaging, or machine vision technologies.
  • Proficiency in working with plastics, injection molding techniques, and the assembly of miniature components.
  • Training or certification in process/operations excellence methodologies (such as Six Sigma, Lean, Green Belt, or Black Belt).
What We Offer

The successful candidate will enjoy:
  • Working with a startup medical device company.
  • A competitive compensation package with comprehensive benefits and equity options.
  • A leadership role with exceptional growth potential.
  • An opportunity to shape the position and make a significant impact.

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