Tooling Engineer

4 weeks ago

Fremont, United States BioTalent Full time

Medical Device Tooling Engineer

We are seeking a highly motivated and detail-oriented Medical Device Tooling Engineer to join our growing team. In this critical role, you will play a key part in ensuring the successful design, development, and implementation of tooling for the production of complex medical devices within a contract manufacturing environment.

Responsibilities:

  • Collaborate with design engineers and project managers to develop and optimize tooling for the production of medical devices using plastics injection molding processes.
  • Utilize CAD software (e.g., SolidWorks, Creo) to design and detail tooling components, including molds, fixtures, and gauges, ensuring compliance with engineering specifications and industry standards.
  • Conduct manufacturability reviews of tooling designs, identifying potential issues and proposing solutions to optimize production efficiency and product quality.
  • Perform Failure Mode and Effects Analysis (FMEA) to identify and mitigate potential risks associated with tooling design and manufacturing processes.
  • Work closely with moldmakers and other manufacturing personnel to ensure accurate and timely fabrication of tooling.
  • Participate in tool trials and qualifications, conducting inspections and analyzing data to verify functionality and adherence to specifications.
  • Maintain thorough documentation of tooling design, development, and qualification processes.
  • Stay up-to-date on industry best practices and regulatory requirements for medical device manufacturing.

Qualifications:

  • Bachelor's degree in Mechanical Engineering or a related field.
  • Minimum 3 years of experience in medical device tooling design and development.
  • Proven experience with plastics injection molding processes, including mold design principles, material selection, and processing parameters.
  • Proficiency in CAD software (SolidWorks, Creo, or similar).
  • Strong understanding of GD&T (Geometric Dimensioning & Tolerancing) principles.
  • Excellent analytical and problem-solving skills.
  • Effective communication and collaboration skills.
  • Ability to work independently and manage multiple projects simultaneously.
  • Meticulous attention to detail and a commitment to quality.
  • Experience with FMEA and other quality control principles a plus.

Benefits:

  • Competitive salary and benefits package.
  • Opportunity to work on cutting-edge medical device technologies.
  • Fast-paced and dynamic work environment.
  • Be part of a team that is making a positive impact on patient lives.

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