Senior Process Engineer

Senior Process Engineer

Location: Tempe, AZ

Duration: 12-month contract

Work Arrangement: Onsite at least 3 days per week (some flexibility)

Responsibilities

• Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with established new product development procedures.
• Ensure quality of process and product as defined in the appropriate operation and material specifications.
• Assist in the selection and design of equipment based on analysis of specifications, reliability, and regulatory requirements.
• Support capital acquisition activities, including specifying equipment, contract negotiation, installation, and validation.
• Write operations manuals, troubleshooting manuals, continuous and preventive maintenance manuals.
• Analyze equipment to establish operating data and conduct experimental test and result analysis.
• Use engineering techniques to reduce product time to market while adhering to regulatory requirements, project deadlines and product costs.
• Participate in process review meetings.
• Participate in process failure mode and effect analysis (PFMEA), control plan, standard operating procedures (SOP) and production part approval process (PPAP) generation associated with product transfers and launches.
• Complete capability studies for in-process inspection and generate subsequent inspection documentation.
• Conduct qualifications, validations, and measurement system analysis (MSA) studies for new products and new processes. Review and approve validation documentation.
• Work in a hands-on manner at the manufacturing site to support the implementation of new processes as specified in development.
• Drive and execute effective communication with all stakeholders to enable project success.
• Provide training for manufacturing team members.
• Ensure adherence to GMP and safety procedures.

Required Qualifications

• 2+ years of relevant work experience.
• Bachelor's degree in Engineering.

Preferred Qualifications

• Lean Six Sigma Green Belt Certification or above.
• Knowledge of manufacturing processes, materials, product, and process design.
• Good understanding of design for manufacturing (DFM), related statistical tools, and validation/verification techniques.
• Experience writing and executing validations.
• Experience in new product introduction or manufacturing engineering.
• Experience in an FDA-regulated or regulated industry.