Device Engineer II

* Contribute to development activities across the device lifecycle, from concept through commercialization.
* Support technical evaluation plans, including hands‑on laboratory testing and oversight of contract lab activities.
* Assist in developing, optimizing, and executing device test methods and characterization studies; support method validation with growing independence.
* Perform and supervise bench‑level experiments, ensuring high‑quality data and adherence to internal procedures.
* Collaborate on fixture, tooling, and prototype design using CAD and 3D printing.
* Support design verification testing and method transfers to external labs or manufacturing sites.
* Author technical documentation including test methods, protocols, reports, design control content, and regulatory submission materials.
* Support quality investigations, CAPAs, and change controls for device testing.
* Contribute to continuous improvement initiatives (e.g., 5S, Kaizen).
* Communicate results, troubleshoot issues, and support technical alignment with Device Engineering, CMC, Quality, Regulatory, and external partners.
* Present findings and study outcomes clearly to project teams and stakeholders.
* Strong problem‑solving abilities and independence in executing testing activities.
* Proficient technical writing skills.
* Working knowledge of design control principles, medical device regulations, and cGMP.
* Familiarity with statistical techniques (e.g., Gauge R&R, normality testing, ANOVA) and statistical software (e.g., JMP, Minitab).
* Master’s and 2+ years of relevant experience OR
* Bachelor’s and 4+ years of relevant experience
* Hands‑on experience with mechanical testing, device characterization, or method development.
* Experience with medical device testing, including test method development, validation, and design verification.
* Proficiency with statistical tools and techniques (e.g., Gauge R&R, normality testing, data transformations, sampling strategies, ANOVA) and software (e.g., JMP, Minitab).
* Experience using CAD software (e.g., Solid Works, OnShape) and 3D printing for fixture or prototype development.
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