Job Description
About the Role
We are looking for a Process Engineer to join the Heparin Coating team in Medical Products. In this role, you will be part of an engineering team focused on supporting daily operations by helping to ensure reliable supply of fit for use coated medical devices to our partners in the medical supply chain. You will provide product support by working hands-on in our manufacturing, chemical processing, inspection, and QC lab areas and partner closely with upstream and downstream supply chain partners to resolve quality issues, manage changes, and drive continuous improvement.
This position will be located at our facility in Flagstaff, Arizona, with the possibility of a hybrid work arrangement.
Responsibilities
- Partner with other engineering and manufacturing team members, support daily operations and equipment sustainment needs through activities such as troubleshooting equipment and process issues using formal problem solving and root cause analysis techniques, driving continuous improvement efforts, and gathering and analyzing data to identify improvement opportunities and solve problems
- Develop and execute equipment and process validations following quality system requirements
- Design experiments, analyze using statistical techniques, and document results per quality system requirements
- Document and communicate technical plans, experimental results, and conclusions of work to satisfy quality system requirements and enable future use of knowledge
- Apply disciplined project practices and project management tools to prioritize, manage, and execute your work to meet timelines
- Appropriately assess and document risks to products and processes
- Collaborate with cross-functional teams to ensure a reliable supply chain is maintained
Required Qualifications
- Bachelor’s degree in Engineering or equivalent with a minimum of 1 year working experience, preferably in a process engineering role in a regulated medical industry
- Understand and apply engineering fundamentals
- Demonstrated strong commitment to product quality
- Demonstrated ability to design experiments, statistically analyze the results and provide data supported decisions
- Self-motivated and directed with the ability to prioritize multiple projects to meet timelines
- Ability to work effectively in team situations while building an inclusive environment, as well as the ability to independently prioritize, initiate and drive projects to completion
- Ability to travel up to 5%
Desired Qualifications
- Experience with quality systems, documentation, review of technical documentation, and methodologies
- Experience with pharmaceutical or medical device regulations, submissions, or working with regulatory bodies
- Experience integrating manufacturing equipment with software systems
This position offers a hybrid work arrangement in the country from which the Associate is employed. Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore’s work arrangement policies.