Test Engineering Manager

Test Engineering Manager

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Varian Medical Systems, a Siemens Healthineers company is seeking a Test Engineering Manager to join our Interventional Oncology (IO) development team. The individual will be a member of our growing embolization product development team that is focused on treating cancers by delivering internal chemical/radiation therapy and occluding the blood supply to tumors. The individual would contribute by leading the testing aspects of design and development related to new implantable therapy and embolization products, as well as managing a team of laboratory technicians. The ideal candidate would be a self-driven individual with a passion for medical device development and a desire to work on products that change people's lives.

What You Will Do:

• Develop and execute complex test plans involving significant data collection and interpretation, assessment of results, and incorporation of step for continuous design improvements
• Lead coordination with external testing agencies and laboratories to evaluate devices
• Support design and development of novel chemical and materials-based devices, including chemical (XRD, DSC, leachable, etc), radiation-related, and mechanical (stiffness, sizing, etc) assessments
• Develop validated methods for process development and production needs for both internal and external testing
• Write technical documentation including process descriptions and test methods
• Lead the R&D team of laboratory technicians including hiring, performance management, and training
• Manage technician resources within and across projects to reach program goals
• Provide technical leadership and guidance to the project team
• Mentor technicians in best practices
• Contribute to and maintain FDA compliant Design History Files (DHF)
• Execute test processes as they relate to quality system compliance with FDA 510(K), QSR and ISO 13485
• Participate in complaint investigations, and failure analysis of products
• Provide root cause analysis support and drive the implementation of corrective action for process-related issues
• Perform other duties as assigned or required

What You Will Have:

• BS in Chemical Engineering, Biomedical Engineering, or related field
• 5+ years of test engineering experience
• 3+ years of laboratory or engineering management experience
• Experience in chemical, radiation, and mechanical testing and test method validation of material-based products
• Experience managing external testing vendor relationships and requirements
• Experience in project resource allocation
• Familiarity with the medical device Regulatory (FDA & MDD) and Quality (QSR & ISO 13485) issues or similarly regulated industry
• Experience in the development of regulated medical devices or combination products is preferred
• Experience with design verification & validation
• Experience working within a company's Quality System
• Excellent organizational skills and attention to detail
• Strong communication skills, both oral and written

What Will Set You Apart:

• Masters Degree or PhD preferred
• Experience assessing and testing Medical Devices
• Laboratory and/or Engineering management in Medical Device environment