Job Description

Description

The Manufacturing Engineer plays a key role in supporting manufacturing operations by executing various aspects of engineering activities such as root cause analysis for non-conformances and customer complaints, validations, production transfers, and continuous improvement projects. This role will also support research and development projects and the introduction of new products across the company.

Primary Responsibilities

• Develops new manufacturing methods using existing or new equipment to ensure repeatability and conformance to customer specifications.
• Evaluate, and improve manufacturing methods, utilizing knowledge of product design, materials and parts, fabrication processes, tooling and production equipment capabilities, assembly methods, and quality control standards.
• Evaluate equipment and processes for repeatability and make improvements as necessary, troubleshoot equipment as needed.
• Interact with the Development team to ensure manufacturability or minimize the risks associated with new products transferred to the Commercial Business Group.
• Develop and run protocols including IQ, OQ, and PQ activities as required.
• Create and revise documents such as Preventative Maintenance, Work Instructions, and Internal Specifications.
• Analyze process outputs using statistical methods to ensure stability.
• Ability to read and interpret CAD or mechanical drawings.
• Partner with Quality department to process change control documentation and participate in investigations as part of deviations and the Corrective Action process.
• Analyze and plan workforce utilization, space requirements, and workflow, and design layout of equipment and workspace for maximum efficiency.
• Partner cross-functionally with internal teams to determine product specifications, material needs, use of equipment, and quality standards to meet customer needs.
• Document processes and train operators and other applicable personnel.
• Support functional departments in reviewing Standard Operating Procedures (SOPs), Work Instructions (WIs), and Preventative Maintenance (PMs) documentation to make process improvements or appropriate revisions.

Other Duties

• Adheres to GMP/QSR requirements and follows applicable QMS documentation (e.g., SOP’s, Work Instructions) to successfully accomplish job requirements.
• Follow Personal Protective Equipment (PPE) policies and procedures, including wearing hearing protection, safety shoes, gloves, eye protection as required.
• Follows gowning procedures in designated areas.
• Follows established safety requirements and adheres to the Health Safety and Environment Management System.
• Performs other job-related responsibilities as assigned.

Qualifications

Qualifications

• Bachelor’s Degree in Engineering or equivalent experience required.
• 1-3 years’ experience in an engineering or similar role within a manufacturing environment.
• Demonstrated ability to lead and manage multiple projects with the ability to meet deadlines and within budget.
• Proficient computer skills using MS Office, MS Project, and strong spreadsheet skills.
• Strong analytical, organizational, teambuilding, and communication skills.
• Lean Manufacturing, Six Sigma, or associated Continuous Improvement methodology training.
• Experience working within ISO 13485 and FDA guidelines.