Senior Engineer, New Product Development (NPD)

Job Overview:

Pay Range: $54.18hr - $59.18hr

Requirement/Must Have:

• Bachelor's degree in engineering required.
• 5-7 years of experience required.
• A minimum of 4+ 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 drawing, schematics and computer-generated reports.

Responsibilities:

• 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, 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.
• Ensures 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 tracks progress against agreed upon targets and deliverables to attain operational metrics required for successful commercialization of products.

Skills:

• Creativity.
• Strong verbal and written communication skills.
• Analytical and problem solving ability.
• Team player.
• Detail oriented.
• Design transfers.
• Process and equipment validation.
• Technical drawing interpretation.
• Six Sigma.
• LEAN.
• DFM.
• MES deployment.

Qualification And Education:

• Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making.