Senior Engineer, Process Engineering

Job Description:
What you will do:
Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the  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.

What you need:
2%2B years of relevant work experience required
Bachelors degree in engineering required
Bachelor\'s degree in Industrial or Systems Engineering highly preferred
Lean Six Sigma Green Belt Certification or above preferred
Knowledge of manufacturing processes, materials, product, and process design preferred
Good understanding of design for manufacturing (DFM), related statistical tools, and validation/verification techniques preferred
Experience writing and executing validations preferred
Experience in new product introduction or manufacturing engineering preferred
Experience in an FDA regulated or regulated industry preferred