Lead Compliance Engineer, R&D

Job Description

Job Description

Our client is a global leader in medical device innovation, dedicated to improving lives through advanced technology and rigorous quality standards. As we expand our portfolio and reach, we are looking for a talented Lead Compliance Engineer to join our Research & Development (R&D) team and drive product compliance for our global markets.

As the Lead Compliance Engineer, R&D, you will define and execute product compliance strategies, policies, and processes to ensure medical products meet regulatory standards and achieve necessary certifications (e.g., ISO, FCC, UL, IEEE). Serving as the technical subject matter expert, you will work closely with regulatory agencies, participate in product design reviews, and guide cross-functional teams to prevent compliance issues from initial design through production and delivery.

You will oversee both internal and external compliance testing, maintain documentation, and ensure supplier adherence to domestic and international requirements. With your wide-ranging experience, you'll resolve complex issues, determine new methods and procedures, and may coordinate activities of other personnel as a team lead.

Key Responsibilities:

• Develop and implement compliance strategies for global regulatory standards (EU MDR, EMC/EMI, safety compliance, etc.) throughout the product lifecycle.
• Serve as the primary technical expert for regulatory compliance, supporting Program Management, Regulatory Assurance, and R&D teams.
• Participate in product design reviews, identify applicable regulatory standards, and provide training to prevent compliance issues.
• Oversee EMC, environmental, and IEC 60601-1 compliance testing at certified labs; act as liaison with agencies such as UL, CSA, TUV, BSI.
• Drive compliance activities for new product launches, post-launch changes, and corrective actions to ensure ongoing regulatory compliance.
• Support internal and third-party audits, prepare and review documentation for test labs and regulatory bodies.
• Create compliance program plans, certification test plans, verification procedures, and reports.
• Collaborate with engineering, marketing, systems, and manufacturing teams to implement compliance requirements into product definitions.
• Manage multiple projects and priorities, contributing to CAPA, cost reduction, EOL, and operations support projects.
• Mentor and train junior engineers as needed.

What we are looking for:

• Bachelor's degree required; Master's or PhD in a technical field strongly preferred.
• 8+ years of experience (or 6+ years with Master's, 3+ years with PhD) in compliance testing for product devices and international certifications.
• Experience with wireless technologies (Wi-Fi, RFID) and electrical test equipment (spectrum analyzers, vector network analyzers, signal generators).
• Strong understanding of medical device compliance and safety standards, device manufacturing, and product lifecycle processes.
• Proficient in EMC design concepts, lab test equipment (multi-meters, oscilloscopes, spectrum analyzers, etc.).
• Ability to troubleshoot and resolve complex EMC issues.
• Experience leading cross-functional teams and projects.
• Logical thinking, mature engineering judgement, and strong analytical/problem-solving skills.
• Effective collaboration and communication skills with technical and non-technical colleagues.
• Proficiency in revision control and at least one software language (e.g., Python).
• Familiarity with FDA, FAA, DoD, ISO environments and risk assessment management.
• Proficient in Microsoft Office Suite (Excel, Word, PowerPoint).
• Ability to mentor and train junior engineers is a plus.