Senior Engineer, Product Stewardship

Main Purpose of the Role

Individual contributor with comprehensive knowledge of materials, chemicals, and product stewardship regulations who evaluates materials used in cardiovascular medical devices and manufacturing processes to ensure compliance with global regulatory requirements (EU REACH, EPR, RoHS, POPs, Stockholm Convention, Conflict Minerals, etc.). Acts as a technical subject matter expert in material composition, restricted substances, and supply chain compliance while supporting divisional Product Stewardship programs.

Main Responsibilities

Compliance

• Comply with all regulations and procedures in scope of the Product Stewardship program.
• Ensures compliance with Product Stewardship requirements through internal processes and implementation of strategies.
• Maintain advanced knowledge of company and global regulatory activities to ensure effective Product Stewardship compliance.
• Track company, industry, and developing regulatory activities to ensure effective Product Stewardship compliance.

Organizational Interface

• Supports the Product Stewardship team and works under the direction of the manager while independently solving day-to-day problems.
• Evaluate materials used in products against regulation requirements based on their intended uses.
• Prepares and reviews written communication.
• Conveys information effectively through formal and informal documents and meetings.
• Following through on goals and incorporates the ideas of others; shares resources, insight, and accountability to benefit the objectives of the business.

Technical

• Evaluate material and chemical compositions against global product stewardship regulations.
• Assess supplier material disclosures, FMDs, IPC-1752A declarations, and substance compliance documentation.
• Review polymers, metals, coatings, adhesives, inks, and electronic component materials for regulatory impacts.
• Partner with R&D during material selection and design changes to identify product stewardship risks.
• Support material risk assessments related to REACH SVHC, RoHS, PFAS, POPs, California Proposition 65, and emerging regulations.
• Provide technical guidance on material substitutions and compliance strategies.
• Build relationships and coordinate data collection from suppliers and TPMs (e.g., Product composition, Conflict Minerals form, Compliance declarations).
• Support the affiliates with Extended Producer Responsibility reporting.
• Identify emerging regulations or new requirements impacting division products; if needed, communicate to the other division functions and ensure actions are put in place.
• Execute a Product Stewardship program that includes division-specific requirements and is aligned with division priorities.

Problem Solving / Innovation

• Address internal and external stakeholders’ needs.
• Explore multiple alternatives to meet the requirements.
• Develop solutions for complex problems when necessary; integrates regulatory and operational needs.
• Leverage expertise to quickly enact tactical decisions and develop strategic plans.

Qualifications

Education Required: Bachelor's degree in Materials Science, Chemical Engineering, Materials Engineering, Mechanical Engineering, Environmental Engineering, Chemistry, or related scientific discipline. Preferred: Advanced degree in Materials Science, Materials Engineering, Mechanical Engineering or related scientific discipline.

Experience: Minimum 4 years of relevant experience. Ability to navigate and interpret medical device product stewardship regulations. Expected to function with little direction and be able to independently drive complex projects to completion. Ability to successfully manage multiple projects and daily responsibilities. Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.