Description

• 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.

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):

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

Preferred Skills (nice to have)

1. Familiarity with relevant standards such as IEC 60601-1, IEC 60601-1-11, ASTM D4169, ASTM D4332, ISTA 3A, and ISO 11607.

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

Key Skills

Education

Bachelor's degree