Engineer II

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.
• Create 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.