Engineer I/II

5 days ago

Salt Lake, Utah, United States ZIEN Medical Full time $80,000 - $120,000 per year

Engineer I/II

ZIEN is a rapidly growing medical device development and manufacturing company that is seeking development engineering talent to help support our growth. We are seeking to fill an engineering position to help support our manufacturing lines and development of new medical devices. In this role the candidate is autonomous and encouraged to be creative in generating solutions. ZIEN strives to create an enjoyable environment where our staff rapidly gain experience and are encouraged to grow skills in their career field through exposure to a broad variety of projects.

Successful candidates will have a passion for developing products and a competence in FDA/ISO 13485 quality systems.

Roles and Responsibilities:

  • Manage product development projects at all stages from concept to transfer, creating products that meet performance requirements within timeline expectations.
  • Generate product specifications based on knowledge of medical devices and research into specific clinical requirements.
  • Mentor and support more junior engineering resources.
  • Provide expertise in mechanical systems and core engineering principles.
  • Provide execution or guidance on process development and validation (IQ/OQ/PQ)
  • Participate with Quality Engineering and Manufacturing to support new product development and ongoing support of manufacturing lines, including monitoring and measurement.
  • Provide support for data analysis and use of statistical techniques
  • Generate and support development of risk analysis documentation (FMEA's)
  • Ensure compliance of procedures and activities to ISO13485/21CFR standards.

Job Requirements:

  • Bachelor's Degree from an accredited university.
  • Up to 5 years of work experience with technical depth/knowledge in Medical Device Engineering.
  • Experience with mechanical assemblies, electrical assemblies, mechanical assemblies, electronics assemblies, or other assembly types
  • Experience with process control systems or equipment designs preferred

We are not currently considering any candidates that require sponsorship for employment visa status (e.g., H-1B visa status, etc.) now or in the future to work legally for our Company.

Job Type: Full-time

Pay: From $80,000.00 per year

Benefits:

  • 401(k)
  • 401(k) matching
  • Health insurance
  • Health savings account
  • Paid time off

Work Location: In person

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