Mechanical / Test Engineer - Medical Device Manufacturing

Genesis10 is seeking a Mechanical/Test Engineer for a 6-month on-site contract position with a leading client in San Diego, CA.

Compensation: $65.00- $75.00 per hour, W2.
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
Test Method Development & Validation

• 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.

Fixture & Equipment Design

• 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.

Manufacturing Process Development

• 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.

Data Analysis & Continuous Improvement

• 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.

Documentation & Cross-Functional Collaboration

• 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.

Required Qualifications

• 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

Preferred Qualifications

• 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

Experience Levels
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

About Genesis10
Ranked a Top Staffing Firm in the U.S. by Staffing Industry Analysts for six consecutive years, Genesis10 puts thousands of consultants and employees to work across the United States every year in contract, contract-for-hire, and permanent placement roles. With more than 300 active clients, Genesis10 provides access to many of the Fortune 100 firms and a variety of mid-market organizations across the full spectrum of industry verticals.

For contract roles, Genesis10 offers the benefits listed below. If this is a perm-placement opportunity, our recruiter can discuss the unique benefits offered for that particular client.

Benefits of Working with Genesis10:

• 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)

For multiple years running, Genesis10 has been recognized as a Top Staffing Firm in the U.S., a Best Company for Work-Life Balance, a Best Company for Career Growth, Diversity, and Leadership, among other things. To learn more and view all our available career opportunities, please visit our website ;br>
Genesis10 is an Equal Opportunity Employer. Candidates will receive consideration regardless of their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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