Norm Compliance Engineer for Medical Devices

Norm Compliance Engineer

Job Title

Norm Compliance Engineer

Job Description

Job title: Norm Compliance Officer

Job Description:

In this role, you will lead Norm Compliance deliverables for Ultrasound products. You will ensure compliance with all applicable standards (IEC and others) throughout the product development lifecycle. Working within cross‑functional teams, you will create and implement compliance plans, support design and testing activities, and manage certification processes with external agencies to enable safe and compliant product releases.

Your role:

• You will ensure Philips Ultrasound products meet global safety and regulatory standards by defining applicable IEC norms, driving end‑to‑end compliance planning, and securing product certifications through external agencies like CSA and TÜV. Your work directly enables safe, reliable, and globally deployable medical systems.
• You will work closely with Systems Engineering, Electrical/Mechanical Design, Software, V&V, and Regulatory Affairs teams. You’ll engage with external certification bodies (CSA, TÜV, UL, BSI) for testing, audits, and approvals, while acting as the technical liaison ensuring standards are correctly interpreted and implemented across subsystems.
•  This role expands your expertise in system‑level safety engineering, EMI/EMC, IEC standards application, and regulatory pathways. You will gain hands‑on experience in test witnessing, troubleshooting certification issues, leading compliance documentation, and training cross‑functional teams, building strong technical leadership in medical device compliance.

You're the right fit if:

• You have 5–8 years of experience in Norm Compliance or Safety Engineering, with hands‑on exposure to medical device development and certification workflows.

• You hold a Bachelor’s degree in Electronics/Electrical Engineering (or equivalent), with strong foundational understanding of system‑level design and safety principles.
• You can interpret and apply IEC standards (60601‑1, 60601‑1‑2, 62304, 62366) at system and subsystem levels, troubleshoot compliance issues, and guide teams across hardware, firmware, and system integration.
• Strong EMI/EMC concepts understanding.

• You are proactive in assessing the impact of standard updates, producing audit‑ready compliance documentation, and collaborating with external labs (CSA/TÜV/UL) for testing and certification.

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
Indicate if this role is an office/field/onsite role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. 
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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.