Senior Compliance Engineer

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 21

CFR 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…