Manager, Chemical & Materials Testing

About the role

Sustainably, Siemens Healthineers is seeking a Test Engineering Manager to join our Interventional Oncology (IO) development team. The role involves leading testing aspects of design and development related to new implantable therapy and embolization products, as well as managing a team of laboratory technicians.

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
• Develop and execute complex chemical and mechanical verification protocols involving significant data collection and interpretation, assessment of results, and incorporation of steps 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
• Perform other duties as assigned or required

Qualifications & Experience

• BS in Chemical Engineering, Biomedical Engineering, or related field; 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

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement plan
• Life insurance
• Long-term and short-term disability insurance
• Paid parking/public transportation
• Paid time off
• Paid sick and safe time

Pay

The Base Pay Range For This Position Is $104,930 - $144,276 Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

Schedule

Not specified