Engineering - Senior Engineer, Process Engineering

Location: Guadalupe

Location: Guadalupe, AZ Salary: $60.00 USD Hourly - $63.00 USD Hourly Description:
Job Title:
Engineering - Senior Engineer, Process Engineering

Location:
Tempe, AZ

Duration: 12+ Months Contract

Job Description:

Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Client 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

Must have:

- 2+ years of relevant work experience

Knowledge of manufacturing processes, materials, product, and process design

Experience with user requirement specifications (URS), process failure mode and effect analysis (PFMEA), standard operating procedures (SOP)

Nice to have:

- Experience writing and executing validations

Good understanding of design for manufacturing (DFM), related statistical tools, and validation/verification techniques

Experience in new product introduction or manufacturing engineering

Experience in an FDA regulated or regulated industry

Qualification:

- 2+ years of relevant work experience

Bachelor's degree in engineering Bachelor's degree in Industrial or Systems Engineering - highly preferred Lean Six Sigma Green Belt Certification or above - preferred

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Contact:
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