Tooling Engineer - Fremont, United States - BioTalent

Description

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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