Sr. Test Engineer - Design Verification Testing

Title: Sr. Test Engineer - Design Verification Testing
Location: San Diego CA 92121
Duration: 6 months – Possible extension
 
Job Description:

• The role focuses on mechanical and electromechanical design verification testing for CGM applicator and wearable systems. Key responsibilities include deployment mechanism verification, environmental conditioning, sterilization impact assessment, force measurements, and IPX8 water ingress testing.
• The primary focus of this position is to lead and execute design verification strategies for mechanical and electromechanical CGM applicator and wearable systems.
• The ideal candidate will have hands-on experience with mechanical testing, deployment mechanism verification, environmental conditioning, and sterilization impact assessment, with a strong understanding of industry standards and regulatory requirements.

 
Key Qualifications:

• Bachelor’s degree in mechanical engineering, Biomedical Engineering, or related discipline (5 years of experience would be great)
• Experience with mechanical testing methods (force measurement, deployment mechanisms, environmental testing)
• Familiarity with IEC 60601-1, ASTM D4169, ASTM D4332, ISO 11607
• Statistical analysis experience (JMP, Minitab)
• Medical device industry experience preferred

 
Required Skills (top 3 non-negotiables):

• Agile Experience – 2 Years minimum
• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline
• Experience with mechanical testing methods including force measurement, displacement, deployment mechanisms, and environmental testing (temperature, humidity, vibration, shock).
• self-driven, technical person with strong interpersonal skills and the ability to manage multiple projects simultaneously.

 
Preferred Skills (nice to have)

• Case Management Experience – 3+ years
• Familiarity with relevant standards such as IEC 60601-1, IEC 60601-1-11, ASTM D4169, ASTM D4332, ISTA 3A, and ISO 11607.

 
Where you come in:

• Collaborate with Mechanical Engineering, Sterilization, Packaging, and cross-functional teams to define product requirements, test strategies, and use cases for CGM applicator and wearable systems.
• Lead and execute design verification strategies for mechanical and electromechanical assemblies, including applicator deployment mechanisms, sensor insertion systems, and housing retention features.
• Design and implement cost-effective test methods for mechanical and electromechanical systems, including force measurements, deployment testing, water ingress protection (IPX8), and environmental conditioning.
• Create and maintain verification documentation, including test plans, protocols, and reports in compliance with ISO 13485, 21 CFR 820, and applicable IEC/ASTM standards.
• Analyze test results using statistical techniques (e.g., t-test, ANOVA, tolerance intervals, equivalence testing), document findings accurately, and provide improvement recommendations.
• Plan and execute assessment of sterilization impact on mechanical performance and sensor deployment integrity.
• Support distribution simulation, environmental conditioning, and packaging verification activities in coordination with packaging engineering.
• Seek opportunities to improve processes, test equipment, and methods, including elimination of non-value-added activities or automation of tedious tasks and tests.
• Design, fabricate, and troubleshoot test fixtures and equipment

 
What makes you successful:

• You have a bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
• Experience with mechanical testing methods including force measurement, displacement, deployment mechanisms, and environmental testing (temperature, humidity, vibration, shock).
• Familiarity with relevant standards such as IEC 60601-1, IEC 60601-1-11, ASTM D4169, ASTM D4332, ISTA 3A, and ISO 11607.
• Knowledge of at least one scripting or high-level programming language (e.g., Python, MATLAB, VBA) for data analysis or test automation.
• Capability to interpret regulatory frameworks and standards and apply them to product design verification and processes.
• Strong analytical and problem-solving skills with experience in statistical analysis tools (e.g., JMP, Minitab).
• Excellent communication skills, both written and verbal, with the ability to present technical data to cross-functional and leadership audiences.
• You are a self-driven, technical person with strong interpersonal skills and the ability to manage multiple projects simultaneously.

 

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's pay range is $60.00/hr – $65.00/hr.