Process Design and Development

Job :
Lake Forest, CA, 92630

Employment Type:

C2CCompany: SRI Tech Solutions

Job Title:

Process Design and Development-:
Lake Forest, CA (Onsite)
Mode:
Contract

Job Description As Principal Engineer, Early Process Design and Development in Lake Forest, CA the ideal candidate will be a senior member of a high performing team, specialized in the design and development of processes, fixtures and test methods used in new product  this role, you will be expected to:

Embed as the Process Design and Development representative on R&D project teams responsible for estimating budgets and timelines for all process design and development activities on a project.

Manage and prioritize multiple projects in a dynamic fast paced R&D environment and be self-accountable to ensure all project goals and objects are completed per committed timelines.

Work well with and collaborate with cross-functional teams as well as provide technical expertise on a project and support both internal and external manufacturing sites as well as 3rd Party Manufacturers Communicate and present project status/risks to Leadership, and Project Leads to ensure adequate support is provided as well as timely escalation of issues to ensure project success.

Collaborate with product design teams to ensure manufacturability of new designs is accounted for to ensure smooth transition from development to production.

Plan, organize, schedule, and manage process design and development activities on projects in order to ensure concurrent engineering of new processes and technologies.

Research, develop and introduce new technologies for use in the fabrication and testing of innovative product designs e.g.Evaluate new products for manual and automated assembly, production, or manufacturing processes.

Design and fabricates prototype equipment and fixtures.

Investigates and integrates leading edge automation technology into new products as appropriate.

Creates CAD files, and pertinent documents for implementation of manual, semi-automated and automated component fabrication and electro-mechanical assembly and final testing.

Supplies knowledge and facilitates execution of process validation activities and documentation e.g. IQ/OQ/PQLeads bench testing method creation for new processes and  able to retrofit existing processes and equipment with updated capabilities and technology.

Work with design engineers and/or vendors to develop solutions to complex problems by designing processes, tools/fixtures that can work with various fabrication and assembly processes and equipment.

Evaluate component, subassembly and/or assembly supplier capabilities and technologies for use in the development of new products.

Coordinates and oversees builds at suppliers and evaluates for design, regulatory and business requirements.

Utilize Six Sigma methodologies such as DMAIC or DFSS to characterize and optimize new process designs, develop performance criteria, equipment, and/or test fixtures.

Utilize risk management tools such as Fault Tree Analysis and Failure Mode and Effects Analysis to understand and quantify risks and understand design or process trade-offs.

Creates and maintains a Process Flow Diagram for manufacturing and assembly of electro-mechanical medical devices.

Creates and maintains initial standard operating procedures and test methods for Design Verification testing and/or manufacturing processes.

Coordinates R&D Pilot Line builds and supports manufacturing builds as part of transfer activities.

Provide coaching, mentoring, and training of team or less experienced engineers to build and strengthen the culture of the organization.

Skills/

Experience:

Exceptional communication and interpersonal skills, with the ability to work effectively at all levels of the…