Product Compliance Specialist

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Varian Medical Systems, a Siemens Healthineers company is seeking an onsite Product Compliance Specialist at our Headquarters in Palo Alto, California. This role will allow some remote/hybrid flexibility but the successful applicant should be prepared to be onsite several days per week.

What You will do:

• Determine the applicable regulations and standards for new and existing products supporting product safety/EMC investigations from inception to obsolescence
• Communicate applicable technical and design requirements to cross-functional and Hardware design teams
• Provide Safety/EMC guidance based on standards expertise and research
• Participate in Risk Management Reviews
• Coordinate activities and assist with interactions during regulatory agency inspections for quarterly Follow Up Services (FUS)
• Update cross-functional teams of test results and compliance status at all design phases
• Manage and coordinate testing of production-level units with third-party laboratories, to ensure continued global compliance and certification
• Maintain certification documents
• International travel, as needed, up to 10%

What You will have:

• Bachelor’s degree in Electrical Engineering, Mechanical Engineering, or similar technical discipline
• 5+ years of experience in EMC safety and/or compliance
• Experience handling product compliance, submitting products for global approvals, and obtaining certifications
• Demonstrated experience with one or more of the following U.S. and international Medical Electric Safety and EMC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-1)
• Proven track record for obtaining NRTL approvals on Medical Devices
• Knowledge of electronics and mechanical design and safety experience overseeing all product-safety aspects of a device’s inception to obsolescence.
• Experience documenting technical requirements extracted from standards experience working with third-party NRTL labs
• Experience with MS Office applications including Excel 

What will set You apart:

• Masters Degree in Electrical Engineering, Mechanical Engineering, or similar technical discipline
• Experience troubleshooting EMC/EMI HW issues.
• Experience with Safety, EMC, Laser, and FDA Guidance requirements for Medical Devices
• Experience with Medical Device Safety Risk Assessments
• Strong analytical skills including statistical analysis
• Strong cross-functional communication skills

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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:

Min $115,980 - Max $173,980

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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