Sr Engineer

Title: Sr Engineer

Pay: $50.00-$57.00/hr

Location: Draper, UT

Duration: 12-Month Contract

Schedule: Standard Office Hours

Responsibilities

• Lead the identification, development, and optimization of manufacturing processes using engineering methodologies such as Lean Manufacturing and Six Sigma to drive continuous process improvement.
• Identify opportunities for equipment, tooling, fixture, and process redesign to improve manufacturing efficiency while reducing overall product and process risk.
• Monitor critical control points and support process control activities.
• Design, develop, and execute engineering experiments and validation activities, including writing and executing protocols to improve manufacturing processes, products, test methods, source materials, and supplier performance.
• Complete process validation activities (TMV, IQ, OQ, PQ), analyze results, and prepare validation reports.
• Partner with cross-functional teams to ensure projects are completed successfully and on schedule.
• Collaborate with engineering teams on equipment selection, qualification, and validation.
• Develop and maintain manufacturing documentation, including work instructions, procedures, and training materials to support knowledge transfer.
• Develop and maintain technical content within risk management documentation.
• Lead investigations into complex manufacturing quality and compliance issues, including NCRs, CAPAs, SCARs, audit findings, nonconforming materials, and Material Review Board (MRB) activities.
• Analyze investigation results, recommend corrective actions, and prepare technical reports.
• Provide technical leadership by training and mentoring engineers, technicians, and manufacturing personnel while overseeing quality support activities.
• Lead, review, and approve engineering change control documentation.
• Ensure compliance with quality system requirements, regulatory standards, and environmental health and safety guidelines.

Required Qualifications

• Bachelor's degree in Engineering or a related scientific discipline.
• 5–7 years of engineering experience in a regulated manufacturing environment.
• Strong understanding of manufacturing processes, quality engineering principles, and process validation.
• Experience with TMV, IQ, OQ, and PQ validation activities.
• Ability to read and interpret engineering drawings.
• Experience applying statistical methods and data analysis to manufacturing processes.
• Proficiency with Microsoft Office Suite.
• Excellent written, verbal, and interpersonal communication skills.
• Strong analytical, organizational, problem-solving, and critical thinking abilities.
• Ability to communicate technical concepts to both technical and non-technical audiences.
• Strong leadership skills with the ability to influence cross-functional teams.
• Experience working independently while managing multiple priorities in a fast-paced environment.
• Demonstrated ability to collaborate effectively across departments and with external partners.
• Strong attention to detail and commitment to quality and compliance.

Preferred Qualifications

• Bachelor's or Master's degree in Materials Science, Mechanical Engineering, Chemistry, or a related field.
• ASQ Certified Quality Engineer (CQE) certification.
• Six Sigma Green Belt certification or higher.
• Experience with automation systems, software testing, and software validation.
• Experience supporting cleanroom or regulated manufacturing environments, including medical device or similarly regulated industries.

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