JOB TITLE:
Engineer II
LOCATION:
Draper, Utah
DURATION:
9 months contract
PAY:
37-42 USD per hour
Job Responsibilities:
In this role, you will support manufacturing and quality engineering initiatives by driving process improvements, equipment validation, process validation, and risk management activities within a regulated medical device manufacturing environment. Key responsibilities include:
- Managing equipment qualification activities, including Installation Qualification (IQ) and TFIQ validations, as well as asset management actions.
- Optimizing manufacturing processes using engineering methodologies such as Lean, Six Sigma, and TOPP to improve efficiency, quality, and reduce process risk.
- Identifying opportunities to redesign equipment, tools, fixtures, and manufacturing processes to improve productivity and manufacturability.
- Collaborating with cross-functional engineering teams to support successful product and process transfers.
- Supporting process validation, production builds, TMV activities, PMV, and Process Validation Plans.
- Developing and maintaining risk management documentation, including pFMEAs and risk management files in collaboration with Business Unit Process Management teams.
- Creating and maintaining manufacturing documentation, including work instructions and training materials, to support knowledge transfer and production readiness.
- Ensuring compliance with company quality systems, engineering standards, and regulatory requirements.
Essential Duties and Job Functions:
- Review and approve equipment qualification documentation, including IQ and TFIQ protocols and reports.
- Support asset management activities for manufacturing equipment.
- Optimize moderately complex manufacturing processes through continuous improvement initiatives.
- Apply Lean, Six Sigma, TOPP, and other engineering tools to improve manufacturing performance.
- Recommend equipment, tooling, fixture, and process improvements that enhance manufacturing efficiency and reduce operational risk.
- Collaborate with engineering and cross-functional teams during product and process transfer activities.
- Develop, update, and maintain technical documentation for risk management files.
- Review and revise Process Failure Mode and Effects Analyses (pFMEAs) in conjunction with Business Unit Process Management teams, as applicable.
- Develop production documentation, work instructions, and training materials to support manufacturing operations.
- Support process validation activities, including validation protocols, production builds, TMV, PMV, and Process Validation Plans.
- Participate in continuous improvement initiatives and manufacturing optimization projects.
- Independently complete engineering assignments while ensuring technical accuracy and compliance with quality requirements.
- Support engineering projects of moderate complexity while contributing to organizational goals.
Knowledge & Skills:
- Solid understanding of engineering principles, theories, and manufacturing concepts.
- Working knowledge of manufacturing processes and production equipment.
- Experience with process validation and equipment qualification activities.
- Familiarity with Lean Manufacturing, Six Sigma, TOPP, or other continuous improvement methodologies.
- Knowledge of risk management tools, including pFMEA.
- Understanding of quality systems and regulatory compliance requirements.
- Strong analytical, problem-solving, organizational, and critical thinking skills.
- Basic knowledge of statistical analysis techniques.
- Experience working with laboratory and/or industrial manufacturing equipment.
- Strong documentation, communication, interpersonal, and relationship management skills.
- Ability to work independently while managing multiple priorities.
- Ability to collaborate effectively with cross-functional teams, vendors, and project stakeholders.
- Strong attention to detail and commitment to quality.
- Proficiency with engineering software and standard computer applications.
Education & Experience:
- Bachelor's degree in Engineering or a related scientific discipline required.
- 2+ years of related engineering experience preferred; or
- Master's degree in Engineering or a related scientific field with relevant internship, senior project, thesis, or industry experience.
- Previous experience in medical device manufacturing or another regulated industry preferred.
- Experience supporting manufacturing process validation and equipment qualification preferred.
- Certified Quality Engineer (CQE) certification preferred.
- Familiarity with manufacturing quality systems and regulatory requirements is highly desirable.
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