Engineer

Sr NPD EngineerThis role in NPD (new product development) is accountable for successful commercialization of new products. The Senior Engineer will also ensure manufacturing processes are developed that meet operational needs for capacity and scale while ensuring cross functional alignment across manufacturing sites in different locations including readiness at suppliers. The Senior Engineer will act as a liaison between R&D, supplier development, quality and sustaining operations to ensure readiness to seamlessly plan, source, make and deliver the product to customers around the world.Bachelor's degree in engineering required. 5-7 years' experience required.Creativity, verbal and written communication skills, analytical and problem solving ability. Team player and detail oriented. A minimum of four years of medical device manufacturing experience is required. Proven track record in design transfers to Operations and process and equipment validation. Experience in developing process requirement specifications, collaborating with external parties, suppliers and working with Operations personnel to establish efficient solution systems. Ability to read and interpret technical drawings, schematics and computer-generated reports. Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making.Support operational transitions through development, clinical, and commercialization including completion of design transfer deliverables to ensure end-to-end readiness. Work cross functionally with pilot, sustaining operations and domestic and international manufacturing locations to harmonize transfer plans and validation strategies across all sites. Drive line and capacity expansion plans in manufacturing locations in collaboration with demand planning and commercial groups for uninterrupted product supply. Ensure development and implementation of robust characterization and validation activities in collaboration with partners from R&D and quality, including deployment of critical control points in manufacturing. Identify manufacturing and sale-up risks at pilot and production sites, and develop and implement appropriate mitigation plans, including business continuity plans at suppliers. Identify and drive continuous improvements in manufacturing processes including opportunities to incorporate digital strategy, automation initiatives, mistake proofing while elevating quality standards. Ensure accuracy of part/drawings, bill of materials (BOM) and other manufacturing documentation. Leads the execution of playbooks to ensure successful assessment and deployment of sourcing, planning, transfer and supplier assessment by PDP phases. Work with cross functional partners to ensure design for manufacturability (DFM), Six Sigma, and LEAN considerations are incorporated into product and process designs, including design and process 3P across sites. Support MES deployment as needed. Provide analysis and track progress against agreed upon targets and deliverables to attain operational metrics required for successful commercialization of products.At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth. Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships. We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options. TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.