Medical Device Engineer - Multiple Openings Job at Astrix, Orange County, CA

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  • Astrix
  • Orange County, CA

Job Description

Are you ready to take your engineering career to the next level? We are looking for talented professionals to join our dynamic team and play a crucial role in shaping the future of medical technology. If you are passionate about innovation, problem-solving, and making a meaningful impact in a highly regulated industry, we want to hear from you.

Why Join Us?

  • Work on cutting-edge medical device technology
  • Collaborate with industry-leading experts in engineering and quality
  • Gain experience in a fast-paced, FDA-regulated environment
  • Competitive compensation, career growth, and a strong team culture

Open Positions

Quality Engineer

Responsible for ensuring manufacturing quality and post-market performance of medical devices. Leads root cause investigations, resolves customer complaints, and collaborates with cross-functional teams to drive compliance with FDA regulations and ISO 13485 standards. Requires a bachelor’s degree in engineering and at least one year of experience in a regulated industry.

Mechanical Engineer / Mechanical Designer

Designs and develops plastic, die-cast, sheet metal, and machined components for advanced medical devices. Responsible for CAD modeling, manufacturing feasibility, and design for assembly. Requires a bachelor’s degree and at least ten years of experience, along with proficiency in Creo Parametric. Experience with Design for Manufacturing (DFM) and Design for Assembly (DFA) is essential.

Electrical / Computer Engineer

Develops and validates advanced test equipment used in the manufacturing of medical devices. Involves hardware and software design, working with custom PCBAs, test instrumentation, and automation tools such as LabVIEW and TestStand. Requires a bachelor’s degree in electrical or computer engineering and at least three years of relevant experience.

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

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