Senior Process Engineer

Randstad USA; Tempe (AZ); Sur place; USD 76 000 - 85 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Dental insurance

Vision insurance

AD&D insurance

Life insurance

Short-term disability

401K plan

Résumé du poste

Randstad USA is seeking a Senior Process Engineer, Advanced Operations in Tempe, AZ. The role focuses on leading new product introductions and driving manufacturing innovation within a sustainability-driven, industry-leading organization.

Requires a Bachelor's in Engineering and 2+ years of related experience, with background in FDA-regulated environments and knowledge of DFM, statistical tools, and Lean Six Sigma principles. Contract position with comprehensive benefits offered.

Qualifications

• Bachelor's degree in Engineering required with 2+ years of relevant experience.
• Experience in new product introduction, manufacturing engineering, and validations within an FDA-regulated industry.
• Knowledge of manufacturing processes, DFM, statistical tools, and Lean Six Sigma (Green Belt or above preferred).

Responsabilités

• Provide hands-on engineering support for NPI, ensuring processes and documentation align with development procedures.
• Oversee equipment selection, design, capital acquisition, contract negotiation, installation, and validation.
• Generate operating manuals, capability studies, inspection documentation, and MSA studies.
• Participate in PFMEA, control plans, SOPs, and PPAP generation for launches and transfers.
• Ensure adherence to GMP, safety, FDA standards, deadlines, and cost targets.

Connaissances

NPI experience

Manufacturing engineering

Validation writing/execution

Design for Manufacturing (DFM)

Statistical tools

Lean Six Sigma Green Belt

Formation

Bachelor's degree in Engineering

Industrial or Systems Engineering preferred

Outils

Statistical tools

Lean Six Sigma methods

Description du poste

Job Summary

Join Our Client in Tempe, AZ as a Senior Process Engineer, Advanced Operations! Shape future medical tech with an industry leader in sustainability. Reqs: Bachelor's in Engineering & 2+ years experience. Spearhead new product introductions and drive manufacturing innovation in a dynamic team.

Location

Tempe, Arizona

Job Type

Contract

Salary

$55 - 62 per hour

Work Hours

8am to 5pm

Education

Bachelors

Responsibilities

• Provide hands-on engineering support for new product introductions (NPI), ensuring processes and documentation align with Our Client's development procedures.
• Oversee equipment selection, design, capital acquisition, contract negotiation, installation, and validation.
• Generate operating manuals, capability studies, inspection documentation, and measurement system analysis (MSA) studies.
• Participate in process review meetings, PFMEA, control plans, SOPs, and PPAP generation associated with launches and transfers.
• Ensure strict adherence to GMP, safety procedures, FDA regulatory standards, project deadlines, and product cost targets.

Qualifications

Bachelor's degree in Engineering required (Industrial or Systems Engineering preferred) paired with 2+ years of relevant work experience.

Demonstrated background in new product introduction, manufacturing engineering, and writing/executing validations within an FDA-regulated industry.

Working knowledge of manufacturing processes, Design for Manufacturing (DFM), statistical tools, and Lean Six Sigma principles (Green Belt certification or above preferred).

Equal Opportunity Employer

Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Randstad Statement

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [e-mail].

Benefits

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

Posting Duration

This posting is open for thirty (30) days.

Additional Qualifications

Bachelor's degree in Engineering required (Industrial or Systems Engineering preferred) paired with 2+ years of relevant work experience.Demonstrated background in new product introduction, manufacturing engineering, and writing/executing validations within an FDA-regulated industry.Working knowledge of manufacturing processes, Design for Manufacturing (DFM), statistical tools, and Lean Six Sigma principles (Green Belt certification or above preferred).