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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.
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.
Responsibilities
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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
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Lead coordination with external chemical test laboratories to evaluate devices
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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
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Validate analytical and mechanical test methods for design verification and process development
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Create verification reports based on test results
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Lead the R&D team of chemical & mechanical laboratory technicians including hiring, performance management, and training
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Manage technician resources within and across projects to reach program goals
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Provide technical leadership and guidance to the project team
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Mentor technicians in best practices
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Contribute to and maintain FDA compliant Design History Files (DHF)
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Execute test processes as they relate to quality system compliance with FDA 510(K), QSR and ISO 13485
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Participate in complaint investigations, and failure analysis of products
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Provide root cause analysis support and drive the implementation of corrective action for process-related issues
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Performs other duties as assigned or required
Qualifications & Experience
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BS in Chemical Engineering, Biomedical Engineering, or related filed; MS or PhD preferred
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5+ years of test engineering experience with preference to assessment of medical devices
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3+ years of laboratory or engineering management experience with preference to experience in medical device or other regulated industry
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Experience in chemical, radiation, and mechanical testing and test method validation of material-based products and devices is preferred
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Experience managing external testing vendor relationships and requirements
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Experience in project resource allocation
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Familiarity with the medical device Regulatory (FDA & MDD) and Quality (QSR & ISO 13485) issues or similarly regulated industry
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Experience in the development of regulated medical devices or combination products is preferred
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Experience with design verification & validation
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Experience working within a company’s Quality System
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Excellent organizational skills and attention to detail
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Strong communication skills, both oral and written
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Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.
How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
To find out more about Siemens Healthineers businesses, please visit our company page here.
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.
If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.
The Company offers the following benefits for this position, subject to applicable eligibility requirements: 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.
Equal Employment Opportunity Statement: Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.
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