Senior Compliance Engineer

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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 sk...