Senior Process Engineer, Advanced OperationsLocation: Tempe, AZPosition SummaryStryker's Sustainability Solutions Advanced Operations team is seeking a
Senior Process Engineer, Advanced Operations to support new product introduction and process development initiatives. In this role, you will be responsible for developing, implementing, and optimizing manufacturing processes that enable the successful launch of new products while ensuring compliance with quality, regulatory, and operational requirements.
Working closely with cross-functional teams, you will play a key role in advancing manufacturing capabilities, driving process improvements, supporting equipment selection and validation, and helping bring innovative products to market efficiently and effectively.
Key Responsibilities- Provide engineering support for new product and process introductions, ensuring all activities are completed and documented in accordance with Stryker's new product development procedures.
- Ensure product and process quality as defined by applicable operational and material specifications.
- Assist in the selection, specification, and design of manufacturing equipment based on performance, reliability, and regulatory requirements.
- Support capital equipment acquisition activities, including equipment specification, contract negotiations, installation, and validation.
- Develop operations manuals, troubleshooting guides, and preventive and continuous maintenance documentation.
- Analyze equipment performance, establish operating parameters, conduct experimental testing, and evaluate results.
- Apply engineering principles and methodologies to reduce time-to-market while maintaining compliance with regulatory requirements, project timelines, and product cost objectives.
- Participate in process review meetings and contribute to project planning and execution activities.
- Support PFMEA, Control Plan, SOP, and PPAP development associated with product launches and product transfer activities.
- Conduct capability studies for in-process inspections and generate associated inspection documentation.
- Execute and support qualifications, validations, and Measurement System Analysis (MSA) studies for new products and manufacturing processes.
- Review and approve validation documentation to ensure compliance and accuracy.
- Provide hands-on support within the manufacturing environment to implement and optimize new processes.
- Drive effective communication across cross-functional teams and project stakeholders to ensure project success.
- Train manufacturing personnel on new processes, equipment, and procedures.
- Ensure adherence to Good Manufacturing Practices (GMP) and established safety requirements.
QualificationsRequired- Bachelor's degree in Engineering.
- Minimum of 2 years of relevant engineering experience.
Preferred- Bachelor's degree in Industrial Engineering or Systems Engineering.
- Lean Six Sigma Green Belt certification or higher.
- Knowledge of manufacturing processes, materials, product development, and process design.
- Understanding of Design for Manufacturing (DFM), statistical analysis tools, and validation/verification methodologies.
- Experience writing and executing validation protocols.
- Experience supporting new product introduction (NPI) or manufacturing engineering initiatives.
- Experience working in an FDA-regulated or similarly regulated industry.
What Success Looks LikeThe ideal candidate is a hands-on engineer who thrives in a manufacturing environment, enjoys solving complex process challenges, and is passionate about bringing new products to market. This individual will combine technical expertise, project execution skills, and strong cross-functional collaboration to deliver robust, scalable manufacturing processes that support business growth and product quality.
