Location:
Irvine, CA (Onsite)
Schedule:
Standard
Duration:
3 month contract (W2)
Pay Rate:$55.00 - $59.00/hr
Position Summary
Our client is a medical device manufacturer with domestic and international manufacturing operations. This New Product Development (NPD) role is accountable for the successful commercialisation of new products. The Senior Engineer will ensure manufacturing processes are developed that meet operational needs for capacity and scale, while driving cross functional alignment across manufacturing sites in different locations, including readiness at suppliers. The role acts 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.
Essential Functions and 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
Education/Experience
- Bachelor's degree in engineering required
- 5-7 years' 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
Knowledge/Skills
- Creativity, strong verbal and written communication skills, and analytical and problem solving ability
- Team player, detail oriented
- Ability to read and interpret technical drawings, schematics and computer generated reports
- Excellent problem solving, organisational, analytical and critical thinking skills, including high discretion and judgement in decision making
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