Service Engineer II

About the Role

The Service Engineer supports digital and manufacturing operations through service engineering activities, process development, tooling design, manufacturing flow optimization, continuous improvement, and related engineering functions. This role provides technical support for equipment design and development, material and process evaluations, specification development, operator instruction creation, process investigations, root cause analysis, problem solving, and technical documentation. The Service Engineer II works independently on assigned projects while collaborating with cross-functional teams to achieve operational and business objectives.

Responsibilities

• Participate in service engineering projects, ensuring assigned tasks are completed on time and meet quality requirements.
• Support investigations related to process issues, including Nonconformances (NCs), customer complaints, audit observations, and Corrective and Preventive Actions (CAPAs).
• Provide technical support and guidance to manufacturing and service operations.
• Develop an understanding of manufacturing processes, tooling configurations, and equipment programs to support process validation activities and engineering studies.
• Perform and support validation activities including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Computer Software Validation (CSV), and Test Method Validation (TMV).
• Identify and implement process improvements using Lean Manufacturing, Six Sigma, and other continuous improvement methodologies.
• Support gauge design, Measurement Systems Analysis (MSA), and implementation activities as needed.
• Operate and utilize measurement equipment including micrometers, calipers, comparators, tensile testers, and coordinate measuring systems to support engineering evaluations.
• Design fixtures and tooling solutions and collaborate effectively with tool designers and equipment suppliers.
• Support the acquisition, installation, qualification, validation, and implementation of new equipment and systems.
• Develop User Requirements Specifications (URS), support equipment selection activities, coordinate validation efforts, and deliver user training.
• Perform programming, setup, troubleshooting, and optimization of manufacturing equipment and measurement systems.
• Prepare and review protocols, reports, procedures, work instructions, and other technical documentation.
• Review engineering drawings and layouts for completeness, accuracy, compliance with specifications, and adherence to company standards.
• Collect, maintain, and analyze engineering data, process documentation, and technical records.
• Participate in Design of Experiments (DOE), capability studies, and engineering evaluations.
• Assist in developing service, manufacturing, and inspection procedures.
• Conduct training on processes, equipment, materials, and procedures as required.
• Ensure compliance with all quality system, regulatory, safety, and environmental requirements.
• Participate in cross-functional teams that may include Manufacturing Engineering, Production, Quality Assurance, Finance, Product Development, Supply Chain, and personnel from other locations.
• Communicate project status, technical issues, risks, and opportunities to management and key stakeholders.
• Serve as a technical resource and mentor to junior service and engineering personnel.
• Support troubleshooting efforts and assist less-experienced personnel in resolving technical challenges.
• Demonstrate leadership by modeling professional behavior, technical excellence, process adherence, and sound decision-making.
• Adhere to all company policies related to quality, health, safety, and environmental requirements.
• Ensure compliance with applicable federal, state, local, and company regulations, policies, and procedures.
• Perform other duties as assigned.

Requirements

• Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related technical discipline from an accredited institution.
• Minimum of 2 years of experience in service engineering, manufacturing engineering, or a related engineering function.
• Experience in a regulated industry, preferably medical devices, pharmaceuticals, or life sciences manufacturing.
• Experience with Lean Manufacturing and/or Six Sigma methodologies preferred.
• Working knowledge of machine and electrical safety principles preferred.
• Demonstrated troubleshooting and root cause analysis skills.
• Strong organizational skills with a results-driven approach.
• Strong written, verbal, and presentation communication skills.
• Proficiency with Microsoft Office applications required; experience with CREO, Minitab, and engineering databases preferred.
• Demonstrated ability to effectively collaborate across functions and organizational levels.
• Proven leadership behaviors including integrity, accountability, innovation, resilience, and continuous learning.

Skills

• Knowledge of manufacturing processes, process validation, and engineering principles.
• Understanding of statistical analysis, process capability studies, and continuous improvement methodologies.
• Experience with root cause analysis and structured problem-solving tools.
• Familiarity with regulated quality systems and applicable industry standards.
• Excellent communication skills with the ability to explain technical concepts to engineering teams, quality organizations, and leadership.
• Ability to work independently and develop practical solutions to complex technical problems.
• Strong organizational, analytical, and project management skills.
• Demonstrated ability to influence and collaborate effectively across functions.
• Self-motivated, resourceful, and adaptable in a dynamic environment.
• Strong teamwork and relationship-building capabilities.

Preferred Qualifications

• Lean Six Sigma Green Belt or Black Belt certification.
• Project Management certification (PMP, FPX, or equivalent).
• Change Management experience or certification preferred.