Senior Compliance Engineer

499x Siemens Healthineers Endovascular Robotics, Inc.; Marquette (MI); 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

Disability insurance

Paid parking/public transportation

Paid time off

Paid sick and safe time

Job summary

499x Siemens Healthineers Endovascular Robotics, Inc. is seeking a Senior Compliance Engineer to lead the compliance engineering and product safety strategy for EVR and related programs.

You will interpret standards, derive system-specific requirements, and guide design teams through requirements from development to verification. The role requires extensive experience in medical device compliance, risk management, and regulatory standards (IEC, ISO, FDA).

Qualifications

• Minimum 8 years of medical device compliance and product safety experience.
• Bachelor's in Electrical, Mechanical, Biomedical, Systems Engineering or a closely related field.
• Willing to travel up to 20%.
• Strong knowledge of IEC 60601-1, 60601-1-2, ISO 14971, ISO 13485, FDA 21CFR 820, IEC 62304, ISO 10993.

Responsibilities

• Lead compliance engineering and product safety strategy for EVR and Monadnock programs.
• Interpret standards and translate clauses into system-specific requirements for design teams.
• Coordinate testing with external verification laboratories and manage lab relationships.
• Support risk management activities and drive remediation of findings.
• Maintain compliance documentation in the quality system and communicate with stakeholders.

Skills

Medical device compliance

Product safety engineering

Risk management

Regulatory interpretation

Education

Bachelor's degree in Electrical/Mechanical/Biomedical/Systems Engineering

Tools

External labs coordination

IEC 60601-1 testing

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 if you 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 interpretingstandards 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

Minimum of 8years 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%

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.

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 learn more, click here.

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 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.

Export Control

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

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.

To all recruitment agencies

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.

Our culture

We are a team of more than 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. 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.