Job Overview
The role of a Staff Process Development Engineer involves developing and implementing approaches to technical problems of moderate scope and complexity. This engineer will use their expertise in engineering techniques to reduce product time to market while adhering to regulatory requirements, project deadlines, and product costs.
Key Responsibilities:
* Provide engineering support for new product and process introductions, ensuring compliance with regulatory procedures.
* Ensure quality of process and product by adhering to operation and material specifications.
* Choose components and equipment based on analysis of specifications, reliability, and regulatory requirements.
* Work with quality engineers to develop component-specific testing and inspection protocols.
* Lead or support capital acquisition activities, including specifying equipment, contract negotiation, installation, and validation.
* Analyze equipment to establish operating data, conduct experimental tests, and result analysis.
* Participate in process review meetings and contribute to PFMEA, Control Plan, SOP, and PPAP generation associated with product transfers and launches.
* Complete capability studies for in-process inspection and generate subsequent Inspection documentation.
* Conduct MSA studies for new products and processes.
* Provide training for manufacturing team members.
This individual will also be responsible for ensuring adherence to GMP and safety procedures, reviewing and approving validation documentation, and performing all other duties as assigned.