Senior Compliance Engineer

Siemens Healthineers; United States; On-site; USD 118,000 - 163,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Long‑term and short‑term disability

Paid parking/public transportation

Paid time off

Paid sick and safe time

Job summary

Siemens Healthineers AG is seeking a Senior Compliance Engineer to lead the compliance engineering and product safety strategy for EVR and related product development efforts.

You will identify applicable standards, translate them into system-specific requirements for design teams, and manage external laboratories for verification testing. The role requires strong documentation, cross-functional collaboration, and mentoring on regulatory standards.

Qualifications

• Minimum of 8 years of medical device compliance and product safety experience.
• Bachelor’s in Electrical, Mechanical, Biomedical, or Systems Engineering.
• Willing to travel up to 20%.
• Hands-on experience with medical device testing and compliance.
• Experience with external laboratories (e.g., TÜV or equivalent).
• Ability to interpret standards and translate to system design/verification requirements.
• Strong documentation and communication skills.

Responsibilities

• Lead compliance engineering and product safety strategy for EVR and other product development efforts.
• Identify applicable standards and derive system-specific requirements for design teams.
• Partner with design engineers across disciplines from requirements through verification.
• Plan, coordinate, and manage compliance testing with external labs and manage lab relationships.
• Participate in design reviews to ensure compliance
• Lead verification planning and write test plans, protocols, and reports
• Support risk management activities and drive findings into requirements
• Track compliance status and drive timely resolution of findings
• Maintain compliance documents within EVR's quality management system
• Communicate with cross-functional stakeholders and mentor on standards

Skills

Medical device compliance

Product safety engineering

Regulatory standards

Laboratory coordination

Design reviews

Documentation skills

Travel up to 20%

Education

Bachelor’s in Electrical, Mechanical, Biomedical, Systems Engineering, or related field

Job description

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.

This is a role well suited to an ambitious professional, looking for the next step in their career. As a Senior Compliance Engineer** , you will be responsible for**:

• Lead compliance engineering and product safety strategy for EVR across the Monadnock program and other product development efforts

• Identify applicable standards and interpret individual clauses in the context of the system, deriving clear, system-specific product safety and compliance requirements for the design teams

• Partner with design engineers (mechanical, electrical, consumables, and software) from requirements development and early design, through design review, to compliance verification

• Plan, coordinate, and manage compliance testing with external verification laboratories, and own the relationships with those labs (e.g., EMC, electrical safety, and other product safety testing)

• Participate in design reviews in a compliance capacity to ensure the design is meeting compliance requirements

• Lead compliance verification planning and execution, and author or co-author compliance test plans, protocols, methods, and reports

• Support risk management activities related to product safety and ensure compliance findings drive appropriate requirements and risk updates

• Track compliance status across the program and drive timely resolution of findings

• Maintain compliance and product safety documentation within EVR’s quality management system

• Communicate clearly and frequently with cross-functional stakeholders and provide mentorship on compliance and standards to design engineers

This position may suit you best ifyou are familiar with what is below, and would like to do develop your career with Healthineers

• Solid, hands‑on experience with medical device compliance testing and engineering required

• Strong working knowledge of the standards applicable to complex active medical devices, i.e.: IEC 60601‑1 (with applicable collateral and particular standards), IEC 60601‑1‑2 (EMC), ISO 14971, ISO 13485, FDA 21CFR 820, IEC 62304, and, for sterile single‑use consumables, ISO 10993 and applicable sterilization standards

• Demonstrated experience working with external compliance and test laboratories (e.g., TÜV or equivalent) to test medical devices required

• Experience interpreting standards and translating clauses into system‑specific design and verification requirements

• Experience with design reviews and design control procedures required

• Strong documentation and communication skills required

Required skills to have for the success of this role

• Minimum of 8 years of medical device compliance and product safety engineering experience required.

• Bachelor’s in Electrical, Mechanical, Biomedical, Systems Engineering, or a closely related field is required

• Willing to travel up to 20%

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:

$118,300 - $162,668

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 Aff... 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.

California Privacy Notice

California residents have the right to receive additional notices about their personal information. To learn more, click here.

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.

Beware of Job Scams

Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers career site.

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.