Senior Process Engineer

System One Clinical & Science; Tempe (AZ); Hybrid; USD 77,000 - 85,000; Part time

Benefits offered by this job

Health benefits

401(k) plan

Dental and vision insurance

Job summary

System One Clinical & Science seeks a Senior Process Engineer in Tempe, AZ for a contract role. You will drive new product introduction process development, focusing on manufacturing processes, technology, and procedures required to bring new products to market.

The ideal candidate has 2+ years of experience, a bachelor’s degree in engineering, and familiarity with GMP/regulatory environments. This role requires hands-on site work and collaboration with cross-functional teams.

Qualifications

• Bachelor’s degree in engineering is required.
• 2+ years of relevant work experience.
• Lean Six Sigma Green Belt Certification or above (preferred). In FDA regulated environments is a plus.

Responsibilities

• Provide engineering support for new product and process introductions, ensuring activities follow NPD procedures.
• Ensure quality of process and product per operation and material specifications.
• Assist in equipment selection and design based on specifications, reliability, and regulatory requirements.
• Support capital acquisition activities including equipment specifications, contract negotiation, installation, and validation.
• Write and maintain operations, troubleshooting, and maintenance manuals.

Education

Bachelor’s degree in engineering

Bachelor's degree in Industrial or Systems Engineering

Job description

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 seekinga 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.

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 seekinga 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 includingMountain 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.