Product Compliance Specialist

591x Varian Medical Systems, Inc.; United States; Vor Ort; USD 139.000 - 191.000; Vollzeit

Benefits dieser Stelle

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Paid parking/public transportation

Paid time off

Paid sick time

Zusammenfassung

Varian Medical Systems, a Siemens Healthineers company, is seeking an onsite Product Compliance Specialist at our Headquarters in Palo Alto, CA. Some remote/hybrid flexibility is available, but onsite presence several days per week is expected.

Responsibilities include determining regulatory requirements, guiding safety and EMC engineering, coordinating third-party testing, and maintaining global certifications throughout product lifecycles.

Qualifikationen

• Bachelor's degree in Electrical/Mechanical engineering or related field.
• 5+ years in product compliance, EMC, electrical safety, or related function.
• Experience obtaining global certifications and managing compliance activities.
• Familiarity with IEC 60601-1/2-1 and NRTL approvals for medical devices.
• Proficiency with MS Office including Excel and documentation tooling.

Aufgaben

• Determine regulatory requirements and standards for new and existing products.
• Provide product safety and EMC guidance to engineering teams.
• Coordinate testing with third-party labs and maintain certifications.
• Communicate compliance updates across design phases and cross-functional teams.
• Support risk assessments and product lifecycle compliance activities.

Kenntnisse

Regulatory compliance

EMC standards

Medical electrical safety

NRTL approvals

Third-party testing

Documentation & certifications

MS Excel

Cross-functional collaboration

Ausbildung

Bachelor's degree

Master's degree

Tools

Microsoft Excel

Jobbeschreibung

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 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.

Product Safety & EMC Compliance

Determine applicable regulatory requirements and standards for new and existing products. Provide product safety and EMC guidance based on standards expertise, interpretation, and research. Support safety and EMC investigations throughout the product lifecycle. Communicate compliance requirements and design considerations to cross-functional and hardware engineering teams. Participate in risk management reviews and product safety assessments. Support compliance activities from product development through end-of-life.

Regulatory & Certification Management

Coordinate testing activities with third-party laboratories and certification bodies. Support global product approvals and ongoing certification maintenance. Assist with regulatory agency inspections and quarterly Follow-Up Services (FUS) activities. Maintain compliance records, certifications, and technical documentation. Ensure continued compliance with applicable global regulatory and industry standards.

Cross-Functional Partnership

Work closely with Engineering, Quality, Regulatory Affairs, and Product Management teams. Communicate compliance status, test results, and certification updates throughout all design phases. Provide technical recommendations related to product safety, EMC, and certification requirements. Support issue resolution related to product compliance and certification activities.

Standards & Technical Expertise

Apply expertise in medical electrical safety and EMC standards to support product development efforts. Interpret standards requirements and translate them into actionable technical requirements. Support compliance strategies for new product introductions and design changes. Assist with investigations related to EMC, EMI, and product safety concerns.

Required Qualifications

• Bachelor's degree in Electrical Engineering, Mechanical Engineering, or a related technical discipline.
• 5+ years of experience in product compliance, EMC, electrical safety, or related compliance functions.
• Experience managing product compliance activities and obtaining global certifications.
• Experience working with medical electrical safety and EMC standards, including: IEC 60601-1 IEC 60601-1-2 IEC 60601-2-1
• Proven experience obtaining NRTL approvals for medical devices.
• Knowledge of electronics, mechanical design, and product safety principles.
• Experience working with third-party testing and certification laboratories.
• Experience developing and documenting technical requirements based on regulatory and industry standards.
• Proficiency with Microsoft Office applications, including Excel.

Preferred Qualifications

• Master's degree in Electrical Engineering, Mechanical Engineering, or related technical field.
• Experience troubleshooting EMC/EMI hardware issues.
• Experience with FDA guidance and regulatory requirements for medical devices.
• Knowledge of laser safety requirements and compliance standards.
• Experience conducting medical device safety risk assessments.
• Strong analytical and problem-solving skills, including statistical analysis.
• Excellent communication and cross-functional collaboration skills.

Additional Information

Based in Palo Alto, California. Hybrid work environment with onsite collaboration required several days per week. Approximately 10% international travel as needed. Opportunity to support innovative medical technologies as part of Varian, a Siemens Healthineers company.

The base pay range for this position is: $139,180 - $191,378. 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.

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

Equal Employment Opportunity Statement

Siemens Healthineers is an Equal Opportunity and Affluent 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.

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 [e-mail].

California Privacy Notice

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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.”

Data Privacy

We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open.

Recruiting Policy

To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.

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.

Our Culture

We are a team of 72,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image‑guided therapy and innovative cancer care, is crucial for clinical decision‑making and treatment pathways. Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.