Senior Process Engineer

System One, Inc.; Tempe (AZ); Hybride; USD 77 000 - 85 000; Temps partiel

Résumé du poste

System One, Inc. is seeking a Senior Process Engineer in Tempe, AZ for a contract role. The position focuses on new product introductions, process development, and manufacturing process optimization to ensure compliance with GMP and safety standards.

The role requires at least 2 years of relevant experience and a Bachelor's degree in engineering. Hybrid work model; responsibilities include equipment evaluation, process validation, and cross-functional coordination to meet project timelines and

Qualifications

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

Responsabilités

• Provide engineering support for new product and process introductions, ensuring activities are completed and documented per NPD procedures.
• Ensure quality of process and product as defined in operating and material specs.
• Assist in equipment selection and design based on specifications, reliability, and regulatory requirements.
• Support capital acquisition activities, including equipment specification, contract negotiation, installation and validation.
• Write operations manuals, troubleshooting manuals, and maintenance manuals.
• Analyze equipment to establish operating data and conduct tests and result analyses.
• Reduce product time to market while meeting regulatory requirements, deadlines, and costs.
• Participate in PFMEA, control plan, SOPs, and PPAP generation for product transfers and launches.
• Complete capability studies for in-process inspection and document results.
• Conduct qualifications, validations, and MSA studies for new products/processes; review validation docs.
• Hands-on work at the manufacturing site to implement new processes.
• Communicate with stakeholders for project success.
• Provide training for manufacturing teams.
• Ensure GMP and safety procedures are followed.

Connaissances

years of experience

Bachelor's degree in engineering

Formation

Bachelor's degree in engineering

Description du poste

Job Title: Senior Process Engineer
Location: Tempe, AZ
Type: Contract
Compensation: $56-$61.95hr
Work Model: Hybrid
Hours: Monday- Friday 8am to 5pm

Overview

We are seeking a Senior Process Engineer, to work on new product introduction process development in Tempe, AZ. This role supports the execution of assigned project elements with an emphasis on the manufacturing process, technology, and procedures required for the manufacture of new products.

Responsibilities

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

Requirements

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

Preferred

• Bachelor's degree in Industrial or Systems Engineering
• 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
• Knowledge of risk-based thinking and statistical concepts is a plus

System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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