The Surgical Solutions New Product Development team is looking for an experienced Process Engineer to support process/product development activities including process design, qualification, and validation in collaboration with a cross-functional team.
Requirements
- Experience with equipment qualification (IQ/OQ) and process validation (POQ/PQ)
- Ability to apply engineering fundamentals and statistical tools to equipment and process design, development, optimization, and troubleshooting activities, ensuring processes are capable, robust, ergonomically sound, and aligned with product-level requirements and specifications
- Ability to identify critical issues and failure modes, creating a framework of action to address these issues and assess root cause including effective risk-based decision making
- Ability to apply formal problem-solving techniques to determine root cause of equipment/process issues
- Experience developing or transitioning processes from R&D to pilot, to large scale commercial
- Demonstrated ability to work effectively within a regulated medical device quality system
Responsibilities
- Provide process design and support for the research & development of new products
- Understand critical process parameters to ensure the process reliably delivers a fit for use product that meets all specifications and customer requirements
- Support and implement new equipment design, development, and validation
- Identify critical uncertainties and apply engineering fundamentals and critical thinking skills to solve technical challenges
- Identify and address opportunities to continuously improve our products and processes; and assess for regulatory, quality, ergonomic, safety, environmental, and cost impact
- Plan and execute technical work using statistical techniques including Design of Experiments (DoE) and Statistical Process Control (SPC)
- Utilize Gore project practices and lean business tools to effectively prioritize, plan, and drive projects from development to completion
Other
- Bachelor’s degree in engineering with minimum of 3 years hands-on engineering work experience post graduation
- Ability to prioritize, plan, and drive multiple projects concurrently from development to completion against agreed upon timelines and deliverables
- Ability to work independently and collaborate effectively as part of a team, including influencing across functions
- Ability to document, communicate, and present technical work effectively
- Ability to travel up to 10%
