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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