PDS&T Engineer I

Role Summary

Leads and supports the design and development of medical devices addressing unmet clinical needs, with emphasis on late-stage support of programs.

Responsibilities

• Participate in prototyping activities to transform concepts into functional devices.
• Create 3D models using SolidWorks for device prototyping and manufacturing.
• Perform laboratory testing, including independently designed experiments to further project goals.
• Support Design Verification (planning, fixture development, method development, test method validation, protocol development, and test execution).
• Conduct statistical analyses using software such as MiniTab or JMP to evaluate data and support design decisions.
• Conduct analyses (e.g. calculations, tolerance analysis, etc.) as needed to improve product and component designs. Develop and execute test plans to ensure product performance and reliability.
• Prepare technical documentation and reports.
• Collaborate with cross-functional teams (R&D, Quality, Manufacturing) to resolve design and process issues.
• Ensure compliance with company and industry standards regarding safety, quality, and regulatory policies (including GxP).
• Willingness and ability to travel both domestic and internationally, up to 10% of the time.

Qualifications

• BS or equivalent education with typically 5 or more years of experience or MS or equivalent education with typically 3 or more years of experience.
• Demonstrated ability to independently design, execute and interpret critical experiments to answer scientific questions.
• Demonstrated ability to learn, understand and master new experimental techniques.
• Ability to multitask and work within timelines.
• Demonstrated scientific writing skills and strong verbal communication skills.