Description

Own the design verification and test strategy for CGM applicator and wearable systems, ensuring compliance with medical device regulations.

This role is on-site.

Responsibilities

• Lead design verification for mechanical and electromechanical assemblies, including deployment mechanisms and sensor insertion systems.
• Design and implement cost-effective test methods for force measurements, IPX8 water ingress, and environmental conditioning.
• Plan and execute sterilization impact assessments on mechanical performance and sensor deployment integrity.
• Analyze test results using statistical techniques (t-test, ANOVA, tolerance intervals) and document findings in verification protocols.
• Design, fabricate, and troubleshoot test fixtures while eliminating non-value-added activities through automation.

Required Skills

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related discipline with 5+ years of experience.
• Hands-on experience with mechanical testing methods: force measurement, displacement, deployment mechanisms, and environmental testing (temperature, humidity, vibration, shock).
• Proficiency in statistical analysis tools such as JMP or Minitab for data analysis and tolerance intervals.
• Experience creating and maintaining verification documentation in compliance with ISO 13485 and 21 CFR 820.
• Ability to design and fabricate custom test fixtures and equipment.
• Strong interpersonal skills with the ability to manage multiple projects and collaborate with cross-functional teams.

Preferred Skills

• Familiarity with relevant standards including IEC 60601-1, IEC 60601-1-11, ASTM D4169, ASTM D4332, ISTA 3A, and ISO 11607.
• Knowledge of scripting languages (Python, MATLAB, VBA) for data analysis or test automation.

Key Skills

Education

Bachelor's degree