Process Development Engineer

Please send the resumes to careers@starkassociatesllc.com or Contact : +1 848-300-0022

Job Title : Process Development Engineer

Duration : 12+ months Contract with possible extension

Location : Lake Forest – IL

Description:

The Process Development Engineer leads the operational readiness during new product development and manufacturing changes for a variety of medical device products. The Process Development Engineer will be Operations champion during the development stages of new products or line extension activities by developing the manufacturing process, providing Design for Manufacturability/Assembly feedback on the design, completing Process Failure Mode and Effects Analyses, leading the transfer builds, ensuring all processes are validated, and executing on all design transfer deliverables.

The Process Development Engineer is responsible for the designing and optimizing of processes required to manufacture new medical devices. Identify and evaluate innovative processing options based on product attributes for products, including evaluation based on technical and economic feasibility. Execute cost-effective systems in order to enhance the speed and quality of processing, and ensure produced items comply with government regulations and industry standards.

Responsibilities

• Process development and optimization through Design of Experiments (DOE)

• Root Cause Investigation utilizing statistical software and process analysis tools such as process mapping, fishbone diagrams, Is/Is not tables, etc.

• Ensure that operations requirements are incorporated into designs during product development.

• Provide leadership to manufacturing locations serving as the communication bridge between the New Product Development (NPD) team and the manufacturing locations

• Develop advanced manufacturing systems and processes to ensure process capability, repeatability & reproducibility in launched product

• Drive cross-functional NPD teams to develop and generate PFMEA

• Participate as a core member of NPD teams and within cross functional NPD team activities such as Design for Manufacturability and Assembly, DFMEA, Design Reviews

• Lead and coordinate operational readiness and design transfer activities with internal and external manufacturing sites.

• Lead project planning with manufacturing locations to determine manufacturing operational requirements including capacity, space, processes, and capital equipment.

• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820 (Design Controls), ISO 13485, and other applicable regulatory requirements.

• Knowledge of pharmaceutical process validation and integration with combination products process validation

• Lead development of quality control plans to ensure adequate checks are established for testing phases and product launch (e.g. Incoming inspection, In-process testing, lot release testing)

• Lead preparation and execution of process readiness reviews with stakeholders to demonstrate operational readiness including process and equipment validations.

• Equipment qualification (IQ, OQ)

• Process Validation (IQ, OQ, PQ)

• Lead development of manufacturing lines utilizing lean manufacturing concepts.

• Assist in the improvement and development of new product development processes to enhance development of robust products while reducing time to market.

• Translate internal and external customer needs into equipment and process requirements

• Experience/Skills

• Equipment Factory Acceptance Testing /SAT

• Experience with process development and optimization

• Experience developing master batch record/Lot History Record inputs and outputs

• Experience with writing manufacturing procedures/SOPs of a process utilizing lean principles (e.g. Poke a Yoke for manual process)

• Experience with equipment software validation

• Experience with incoming inspection/First article inspections drafting and execution

• Experience utilizing risk documentation and engineering rationale to define in-process testing requirements and lot release testing and sample sizes

• Experience developing Bill of Materials (BOM)

• Experience with engineering, and validation build management

• Experience with design transfer activities and checklist

• Equipment IQ, OQ

• Process Validation (IQ, OQ, PQ)

• Experience with test method validation and test method transfer from R&D site to production facility

• Process control development and implementation

• Design of Experiments (DOE)

• Experience utilizing statistical software such as Minitab for process capability, control charts, trend analysis

• Production specification management (drawings, change control, transferring development specifications into production specifications)