Process Engineer (Sustaining)

Essential Duties and Responsibilities: 

• Process Optimization: Evaluate existing manufacturing processes, identify inefficiencies, and develop strategies to optimize them for improved quality, cost-effectiveness, and efficiency.


• Root Cause Analysis: Investigate and analyze production issues, defects, or inefficiencies to identify the root causes. Work with cross-functional teams to implement corrective and preventive actions.


• Quality Improvement: Collaborate with quality control teams to enhance product quality. Implement quality control measures, conduct tests, and develop protocols to maintain high-quality standards.


• Cost Reduction: Identify cost-saving opportunities within production processes without compromising product quality or safety.


• Continuous Improvement: Implement continuous improvement methodologies such as Lean Six Sigma to drive efficiency, reduce waste, and enhance overall productivity.


• Data Analysis: Analyze production data to identify trends, patterns, and areas for improvement. Use statistical tools and software to make data-driven decisions and implement process enhancements.


• New Process Implementation: Work with product development teams to introduce new manufacturing processes or technologies. Ensure seamless integration of new processes into existing production systems.


• Documentation: Maintain accurate and up-to-date documentation of processes, procedures, and changes. Ensure compliance with regulatory standards and internal quality management systems.


• Cross-functional Collaboration: Collaborate with different departments such as engineering, quality assurance, supply chain, and production to address process-related challenges and implement improvements.


• Training and Knowledge Transfer: Provide training to production staff regarding updated processes, best practices, and new technologies. Facilitate knowledge transfer to ensure the workforce is proficient in implementing optimized processes.


• Supplier Collaboration: Work closely with suppliers to maintain the quality of raw materials and components. Address any quality issues with suppliers and collaborate on solutions to maintain consistency in the supply chain.


• Regulatory Compliance: Stay updated with industry regulations, standards, and compliance requirements related to manufacturing processes. Ensure that the company's processes align with these regulations.


• Cost-Benefit Analysis: Evaluate the costs and benefits of process changes or investments in new technologies. Provide insights to management to support decision-making processes.


• Project Management: Manage projects related to process improvements, ensuring timely completion, budget adherence, and successful implementation of changes.

Knowledge, Skills & Competencies:

• Thoroughly understands how to read and interpret Geometric Dimensioning and Tolerancing (GD&T) callouts on part prints to effectively run quality parts. 


• Must be adaptable to a changing environment, competing demands and is able to deal well with frequent change, delays, or unexpected events.

• Autodesk Inventor or SolidWorks experience Preferred.

• Critical thinking and advanced decision-making skills.


• MS 365 Proficiency.


• Ability to identify different materials and their relationship to design (form, fit, and function).


• High level of attention to detail and meticulous record-keeping capability.


• Excellent prioritization and organizational skills to manage multiple responsibilities.


• Ability to read, comprehend, follow, and document work instructions, blueprints, routers, and standard operating procedures.


• Ability to collaborate and assist team members, provide input to the area lead, and attend/participate effectively in meetings.


• Ability to communicate and interact effectively, professionally, and constructively. 


• Comply with and maintain 5S and safe work environment practices. 


• Experienced in a medical device, ISO/FDA, job shop environment preferred.

Work Environment: 

The work environment characteristics described below are representative of that which an employee encounters while performing the essential functions of this job in a manufacturing environment.

• The noise level in the work environment is usually moderate.


• 100% of time is spent in manufacturing plant environment.


• Regularly works around moving mechanical parts.

Wear common protective or safety equipment such as safety glasses, gloves, and hearing protection

Education, Experience, Certifications, and/or Licenses Requirements: 

• Bachelor’s degree in Engineering or related technical field; or equivalent combination of related experience and/or training.


• Technical degree preferred. Will accept High School Diploma, Trade School (with equivalent work experience.)

• Minimum of 3 years in ISO/FDA machine shop, contract manufacturer experience required.