Design Engineering Manager

4 weeks ago


Stoughton, United States Primo Medical Group Full time
Job DescriptionJob Description

We are seeking a Design Engineering Manager to join our team

Summary:

The Design Engineering Manager will lead the design and development engineering team for our contract manufacturing operations, focusing on medical device projects from concept to production. This role is pivotal in ensuring that our designs meet client specifications, regulatory standards, and our internal quality benchmarks. The ideal candidate will have a strong engineering background in medical devices, a robust understanding of contract manufacturing processes, and proven experience in design for manufacturability (DFM) and design for assembly (DFA).

Essential Duties and Responsibilities:

  • Lead, mentor, and develop a team of design engineers to deliver high-quality and innovative medical device solutions.
  • Manage project timelines, resources, and budgets for design engineering initiatives, ensuring timely delivery and adherence to specifications.
  • Collaborate cross-functionally with Quality, Production, and Regulatory teams to ensure that engineering designs align with manufacturing capabilities and quality standards.
  • Oversee the design and development of new medical device products, ensuring compliance with industry standards (ISO 13485, FDA 21 CFR Part 820, etc.) and client requirements.
  • Drive DFM and DFA efforts to optimize product designs for efficient, scalable production.
  • Conduct design reviews, risk assessments, and FMEA to identify and mitigate potential design and manufacturing issues early in the development process.
  • Provide technical direction on material selection, tolerance analysis, prototyping, and testing to meet both design intent and manufacturability.
  • Solve complex engineering challenges, applying sound principles and innovative solutions to ensure product safety, reliability, and performance.
  • Implement continuous improvement initiatives focused on enhancing design processes and reducing lead times and manufacturing costs.
  • Ensure all design engineering activities comply with applicable regulatory and quality requirements.
  • Prepare and maintain detailed technical documentation, including design history files (DHF), risk management files, and product specifications to support regulatory submissions and audits.
  • Work closely with clients to understand project requirements, provide technical guidance, and ensure satisfaction with delivered products.
  • Address and resolve client concerns related to design and manufacturability, providing timely solutions and proactive support.

Supervisory Responsibilities:

Serve as Technical Lead / mentor with Mechanical Engineering Design group as required.

Qualifications:

  • A bachelor’s degree in mechanical engineering, Biomedical Engineering, or equivalent is required; an advanced degree in any of these fields is preferred.
  • A minimum of 8 years of experience with a proven track record of successful design within a regulated product development environment; medical device is preferred.
  • At least 3 years in a leadership or management role within a contract manufacturing or medical device design environment.
  • Experience in Solidworks is a must.
Company DescriptionPrimo Medical Group, Inc. is a leader in the development of medical devices and precision machined components with currently four locations.

Primo Medical Group, Inc. is an Equal Opportunity Employer and may offer reasonable accommodation to enable individuals with disabilities to perform the essential functions of the position.Company DescriptionPrimo Medical Group, Inc. is a leader in the development of medical devices and precision machined components with currently four locations. \r
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Primo Medical Group, Inc. is an Equal Opportunity Employer and may offer reasonable accommodation to enable individuals with disabilities to perform the essential functions of the position.

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