Engineer II

Job Summary 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. 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. #J-18808-Ljbffr