Edwards Lifesciences Product Stewardship Engineer II in Irvine, California
The Product Stewardship Engineer will ensure Edwards devices meet the material compliance requirements of regulations mandated by global regulatory bodies to ensure patient safety. The Product Stewardship Engineer will evaluate and report compliance status for Commercial and New Products in the Implant Network. This role will require in-depth understanding of the product assemblies, functionality, patient contact levels, and the components and materials used in the manufacture of Edwards’ devices. The Product Stewardship Engineer will also perform periodic gap assessments of existing objective evidence and create an action plan to collect additional information and draft technical justifications as required to mitigate new compliance risks due to regulation updates, new product development, and/or material changes. This will include working cross-functionally with key business stakeholders, interacting with suppliers, and conducting external laboratory testing to gather the required material data. The Product Stewardship Engineer will prepare technical reports to document the material compliance of each product lin accordance with applicable regulations critical for new product launches as well as continued market distribution of current products in an increasingly restrictive regulatory landscape for medical devices.
Essential job functions:
Write material compliance reports for Commercial and NPD products in the Implant Network.
Conduct & participate in cross-functional meetings, workshops, forums, and associated events, as product steward representative for the Implant Network.
Monitor and stay up-to-date on current regional material regulations for Medical Devices (REACh, RoHS, MDR, California Prop 65, Conflict Minerals, Waste Framework Directive)
Work and collaborate with internal cross functional team (Manufacturing, Quality, R&D, Regulatory, and Supply Chain) to ensure compliance objectives are met for relevant regulations and products.
Acquire in-depth knowledge of Implant Network products in relation to product assembly, product functionality, patient contact level, and components and materials used in the device.
Collect objective evidence to assert regulatory compliance for materials and chemicals used in the manufacture of Edwards products. Objective evidence collection effort will include:
Review of internal historical data that may support the material compliance assessment (component drawings, Safety Data Sheets, supplier surveys, supplier certificates).
Contacting suppliers to request Safety Data Sheets (SDS), Certificates of Conformance/Analysis (CoC, CoA), Full Material Disclosures (FMD), and/or compliance statements.
Managing analytical testing of materials with external contract labs, which will include sourcing materials from inventory, addressing product-related questions, reviewing lab reports, and writing technical summaries for received test reports.
Evaluate and report product compliance status to Regulatory stakeholders for upcoming device submissions.
Perform periodic compliance gap assessment for the Cardiac Implant Network to address regulation updates, new product launches, and/or post-commercial material changes.
Produce technical justifications to demonstrate patient safety for instances where materials are identified to contain restricted substances.
Bachelor’s Degree in Materials Science, Chemistry, Chemical Engineering, or scientific discipline.
Minimum 4 years industry experience in Environmental, Health, Medical Devices, or regulated environment.
Product stewardship experience.
Previous experience with product stewardship and material compliance regulations for Medical Devices is strongly preferred.
Ability to read and understand engineering drawings, Technical Data Sheets (TDS), Safety Data Sheets (SDS), and other material specification documents.
Effective communication and technical writing skills.
Ability to work well both independently and in a cross-functional team environment.
Strong analytical and critical thinking skills.
Strong interpersonal skills.
Ability to manage priorities with a strong sense of urgency in a fast-paced environment.
Good project management skills.
Proficient in MS Office Suit.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.