Mechanical / Test Engineer - Medical Device Manufacturing

Description:
We support the development of next-generation medical devices by building and operating pilot manufacturing lines used for prototype, evaluation, and validation of new product designs. These lines replicate production processes and generate the manufacturing and test data needed to advance products toward full-scale production.

We are seeking a Mechanical or Bioengineering professional with medical device experience to support both manufacturing process development and test method development. This role will design and validate test methods, develop custom test fixtures, and support the implementation of manufacturing processes used in early-stage production environments.

The ideal candidate has hands-on experience with CAD-based fixture design, manufacturing process development, and validation of mechanical or dimensional test methods within a regulated medical device environment.

Responsibilities

• Develop and validate test methods using Measurement System Analysis (MSA) and Gauge Repeatability & Reproducibility (GR&R) methodologies.
• Lead Test Method Validation (TMV) activities, including protocol development, execution, analysis, and reporting.
• Design and execute mechanical and/or dimensional testing methods, ensuring measurement reliability and repeatability.
• Work with vision-based measurement systems and dimensional inspection tools where applicable.
• Clearly document and communicate what is being measured, how it is measured, and the purpose of the testing.

• Design and develop custom test fixtures and equipment using SolidWorks or similar CAD tools.
• Produce engineering drawings and prototypes for testing setups.
• Implement fixtures and test systems into pilot manufacturing environments.

• Support the development and optimization of manufacturing processes used in pilot production lines.
• Work with manufacturing processes such as:

  • Liquid or wet dispense

  • Mechanical assembly

  • Bonding

  • Heating or thermal processes

  • UV curing or coating processes
• Develop and document process steps, operating procedures, and equipment requirements.

• Perform Design of Experiments (DOE) to characterize and optimize processes or test methods.
• Analyze data using statistical tools such as JMP or Minitab.
• Evaluate process and measurement performance and identify opportunities for improvement.

• Author validation documentation, including protocols, reports, and risk assessments within a regulated quality system.
• Partner with R&D, Quality, and Manufacturing teams to ensure processes and test methods meet product and regulatory requirements.

• BS in Mechanical Engineering or Bioengineering
• Medical device industry experience required
• CAD experience (SolidWorks or equivalent)
• Experience developing or validating mechanical or dimensional test methods
• Experience supporting manufacturing processes in a regulated environment
• Strong ability to explain testing methodology, measurements, and validation approach

• Experience with Measurement System Analysis (MSA) and Gauge R&R
• Experience performing Test Method Validation (TMV)
• Experience with liquid/wet dispense processes
• Experience with mechanical testing (compression, tensile, etc.)
• Experience with vision systems or dimensional measurement tools
• Statistical analysis using JMP or Minitab
• Familiarity with DOE, SPC, or Six Sigma methodologies

Senior Engineer (Preferred)

• 6-9 years of experience

• Experience with both manufacturing process development and test engineering

Engineer II (E2)

• 4-6 years of experience

• Strong background in either process development or test engineering, with exposure to the other

• Access to hundreds of clients, most of whom have been working with Genesis10 for 5-20 years.
• The opportunity to have a career-home in Genesis10; many of our consultants have been working exclusively with Genesis10 for years.
• Access to an experienced, caring recruiting team (more than 7 years of experience, on average)
• Behavioral Health Platform
• Medical, Dental, Vision
• Health Savings Account
• Voluntary Hospital Indemnity (Critical Illness & Accident)
• Voluntary Term Life Insurance
• 401K
• Sick Pay (for applicable states/municipalities)