Position Title: Senior Engineer (New Product Development) Work Location: Irvine, CA 92614 Assignment Duration: 3 Months Work Arrangement: Onsite
Position Summary:
This 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 meets operational needs for capacity and scale while ensuring cross functional alignment across manufacturing sites in different locations including readiness at suppliers.
Background & Context:
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.
Key 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
Qualification & Experience:
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 drawing, schematics and computer-generated reports.
Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
Bachelor's degree in engineering required.
5-7 years experience required.
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's pay range is $55.00/hr - $60.00/hr.
