Manager, Chemical & Materials Testing

Responsibilities

• 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
• Lead coordination with external chemical test laboratories to evaluate devices
• Development and execution of complex chemical and mechanical verification protocols involving significant data collection and interpretation, assessment of results, and incorporation of step for continuous design improvements
• Validate analytical and mechanical test methods for design verification and process development
• Create verification reports based on test results
• Lead the R&D team of chemical & mechanical 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
• Performs other duties as assigned or required
• Qualifications & Experience
• BS in Chemical Engineering, Biomedical Engineering, or related filed; MS or PhD preferred
• 5+ years of test engineering experience with preference to assessment of medical devices
• 3+ years of laboratory or engineering management experience with preference to experience in medical device or other regulated industry
• Experience in chemical, radiation, and mechanical testing and test method validation of material-based products and devices is preferred
• 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
• #LS-OS1

Benefits

Additional Information

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. 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. Siemens Healthineers is seeking a Manager; Chemical & Mechanical Testing 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.

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