Medical Device Engineer

4 weeks ago


Hopkinton, New Hampshire, United States Michael Page Full time

The NPI Engineer will play a vital role in designing and developing innovative medical devices. Key responsibilities include creating assembly and test fixtures, assisting with validation studies, and optimizing processes to ensure compliance with industry standards.

Key Responsibilities:

  • Design and develop assembly and test fixtures independently, implementing Design for Assembly (DFA) improvements for complex medical device assemblies.
  • Assist in the execution of validation and qualification studies for medical device assemblies, ensuring compliance with regulatory standards.
  • Identify and implement line balancing and process optimization activities with minimal oversight to enhance production efficiency.
  • Provide effective training on medical device assembly processes and formats Manufacturing Process Instructions according to best practices.
  • Work independently to solve complex problems, leveraging input from senior colleagues as needed, while adhering to Design Controls and Quality SOPs.
  • Demonstrate a strong understanding of ISO 13485, participating in audits and guiding junior engineers on compliance matters.
  • Author proposals and project timelines with guidance and participate in client calls as a secondary technical resource, effectively communicating customer needs.
  • Maintain a growth mindset by actively seeking feedback, demonstrating leadership through mentorship, and adapting positively to changing priorities.

Requirements:

  • 3+ years of experience in medical device design and development.
  • Proficient in Microsoft Office (Teams, Excel, PowerPoint, Outlook).
  • Familiar with ISO 13485 and 21 CFR regulations.
  • Basic skills in SolidWorks.
  • Understanding of materials science and properties of medical device materials.

What We Offer:

  • Competitive salary based on knowledge and experience.
  • Comprehensive benefits package available.
  • Includes medical, dental, and vision coverage.
  • Life insurance offered as part of the benefits.
  • 401(k) retirement plan available.
  • Paid holidays included in the benefits package.

Michael Page is an equal opportunities employer and welcomes applications from all qualified candidates.


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