Sr NPD Manufacturing Engineer role provides support and oversight of new product development manufacturing engineering for a class III, implantable device for Edwards' comprehensive portfolio of treatments for structural heart disease within the Surgical BU. The Senior Engineer will support the Global Supply Chain Network by managing engineering activities from early product development through product launch. This role is accountable for successful commercialization of new products. The Senior Engineer will also ensure that design and manufacturing processes are characterized, robust, scalable utilizing best technologies, reflect standard work, are capable and compliant with Regulatory requirements and are validated for Design Control, Manufacturing using LEAN Six Sigma, Design for Manufacturing and Design for Cost Methodologies. The Senior Engineer will act as a liaison between R&D, Supplier Development, Quality and Operations team members assigned to the project. The position will report to the Manager of NPD Engineering and work directly with the Manager of Ops Integration
- Operations technical leader for new products in the PDP process and its main interface between R&D, Pilot, and commercial manufacturing
- Support operational transitions through development, clinical, and commercialization phases and ensure completion of Design Transfer
- Responsible for the development of applicable Process Development (IQ/OQ/PQ) protocols and provide support for execution of validation plans and reports
- Manage pilot production builds, planning, tracking and execution
- Drive the development and manage the execution of complex experiments and tests (including writing an executing protocols) on new or existing product lines to qualify and validate manufacturing processes, analyze results, make recommendations, and develop reports
- Responsible for Characterization and Validation activities, including CTQ flow-down and identification of critical control points within manufacturing
- Leads development of pFMEA
- Deploy manufacturing risk assessment and mitigations, including hands on and resourceful action plans
- Responsible for part/drawing release, and accuracy of the Bill of Materials (BOM)
- Review engineering product specifications, CAD data/drawing, as part of design review process to ensure they meet industry and manufacturing standards and practices
- Ensure DFM, Six Sigma, and LEAN considerations are incorporated into product and process designs, including design and process 3P
- Provide analysis and track progress against agreed upon targets and deliverables
- A bachelor’s degree in engineering is required.
- Minimum of four years of manufacturing engineering experience is required.
- Medical device manufacturing experience preferred
- Proven track record in design transfers to Operations and process, equipment validation experience
- Understand injection molding, polymers and commonly used materials in the medical device space, such as Nitinol and implantable, with working knowledge of metals processing
- Experience in developing process requirement specifications, collaborating with external parties, and working with Operations personnel to establish efficient solution systems
- Technical expertise in the area of manufacturing engineering: design for manufacturability, design and process excellence methodologies including Six Sigma, LEAN experience, cGMP, EH&S guidelines, supplier development engineering and process validation.
- Excellent communication and interpersonal skills at all levels of employees including upper management, suppliers, operators and external parties.
- Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
- Must be willing and able to travel up to 20% domestically, if required
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.