Senior Engineer, Medical Device NPD - Onsite Irvine

Hydrogen UK Ltd; Irvine (CA); On-site; USD 76,000 - 81,000; Full time

Job summary

Hydrogen UK Ltd is seeking a Senior Engineer for New Product Development in Irvine, CA. This on-site, 3-month contract focuses on commercialisation of new medical devices and leading cross-functional transfer and validation across multiple sites.

The role requires a Bachelor's degree in engineering with 5-7 years of experience, including medical device manufacturing and proven design transfer expertise. You will collaborate with R&D, supplier development, quality, and operations to ensure

Qualifications

• Bachelor's degree in engineering required.
• 5-7 years of experience required.
• A minimum of four years of medical device manufacturing experience is required.
• Proven track record in design transfers to Operations and in process and equipment validation.
• Experience developing process requirement specifications, collaborating with external parties and suppliers, and working with Operations personnel to establish efficient solution systems.

Responsibilities

• Support operational transitions through development, clinical and commercialisation, 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 harmonise 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 characterisation and validation activities in collaboration with partners from R&D and quality, including deployment of critical control points in manufacturing
• Identify manufacturing and scale 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 and mistake proofing while elevating quality standards
• Ensure accuracy of parts and drawings, bill of materials (BOM) and other manufacturing documentation
• Lead 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 targets and deliverables to attain the operational metrics required for successful product commercialisation

Skills

Cross-functional collaboration

Communication skills

Analytical problem solving

Reading technical drawings

Team player

Education

Bachelor's degree in engineering

5-7 years experience

Job description

Hydrogen UK Ltd is seeking a Senior Engineer for New Product Development in Irvine, CA. This on-site, 3-month contract focuses on commercialisation of new medical devices and leading cross-functional transfer and validation across multiple sites.

The role requires a Bachelor's degree in engineering with 5-7 years of experience, including medical device manufacturing and proven design transfer expertise. You will collaborate with R&D, supplier development, quality, and operations to ensure