Test Engineering Manager

Varian Medical Systems Inc

AUS S

JOB DETAILS
SALARY
$104,930–$144,276 Per Year
SKILLS
Best Practices, Biomedical Engineering, Chemical Engineering, Communication Skills, Compensation and Benefits, Corrective Action, Data Collection, Dental Insurance, Design Verification, Detail Oriented, Disability Insurance, Disease, Diversity, Engineering, Engineering Management, FDA (Food and Drug Administration), FDA Requirements, Failure Analysis, Geography, Health Insurance, Healthcare, ISO (International Organization for Standardization), Implants, Import/Export, Laboratory, Laboratory Analysis, Laboratory Management, Legal, Life Insurance, Materials Testing, Mechanical Testing, Medical Equipment, Medical Tests, Mentoring, Oncology, Organizational Skills, Performance Management, Presentation/Verbal Skills, Process Development, Product Development, Public Transport, Quality Assurance Methodology, Quality System Requirements (QSR), Radiation Therapy, Recruiting/Staffing Agency, Regulations, Research & Development (R&D), Resource Management, Root Cause Analysis, Supplier Relationship Management (SRM), Team Lead/Manager, Technical Leadership, Technical Writing, Test Lab, Testing, Treasury, Validation Testing, Vendor/Supplier Relations, Vision Plan, Writing Skills, X-Ray Diffraction
LOCATION
AUS S
POSTED
30+ days ago

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.

Job Summary

Develop and execute complex test plans involving significant data collection and interpretation, assessment of results, and incorporation of steps 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.

Requirements

  • 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
  • Working experience 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

About Us

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.

Benefits and Compensation

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 Companys 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.

EEO is the Law

Applicants and employees are protected under Federal law from discrimination. To learn more, click here.

Reasonable Accommodations

Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations.

If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you're unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at peopleconnectvendorsnam.func@siemens-healthineers.com. Please note HR People Connect People Contact Center will not have visibility of your application or interview status.

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Export Control

"A successful candidate must be able to work with controlled technology in accordance with US export control law."

"It is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations."

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About the Company

V

Varian Medical Systems Inc