Process Development Engineer III

About the role

The primary purpose of this position is to apply engineering knowledge and technical problem-solving skills to support process development, manufacturing, and product realization activities. This role is responsible for executing engineering assignments of moderate scope and complexity under the guidance of a Project Manager, Senior Engineer, or Engineering Manager, while serving as the primary technical lead for selected projects.

Responsibilities

• Ensure that Integer's internal and external customer expectations are met or exceeded through effective engineering practices, quality compliance, and continuous improvement.
• Support process development activities for new product introduction, product transfers, and process improvement initiatives.
• Execute engineering projects and assignments under the guidance of Project Managers and Senior Engineers while independently managing assigned workstreams and deliverables.
• Serve as the primary technical lead for selected projects of limited to moderate complexity.
• Develop and optimize manufacturing processes to achieve safety, quality, delivery, and cost objectives.
• Participate in process characterization activities and utilize data-driven methods to establish robust manufacturing processes.
• Support and execute process validation activities including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Test Method Validation (TMV).
• Develop, review, and maintain technical documentation including protocols, reports, work instructions, specifications, engineering studies, and validation documents.
• Investigate manufacturing issues, perform root cause analysis, and implement corrective and preventive actions.
• Collaborate with cross-functional teams including Quality, Manufacturing, Operations, Supply Chain, R&D, and Regulatory Affairs to achieve project objectives.
• Support equipment selection, qualification, and implementation activities as required.
• Develop and maintain effective working relationships with internal and external stakeholders.
• Contribute to continuous improvement initiatives that improve product quality, process capability, productivity, and operational efficiency.
• Perform other duties as assigned by management.

Requirements

• Bachelor's Degree in Engineering or a related technical discipline is required.
• Typically, 5-8 years of engineering experience in medical device manufacturing, process development, manufacturing engineering, or a related technical field.
• Working knowledge of medical device manufacturing processes, particularly cleanroom assembly and related technologies.
• Experience with one or more of the following: laser welding, resistance welding, injection molding, silicone molding, or sterile packaging.
• Understanding of Design Controls and medical device product development processes.
• Experience executing process characterization studies and validation activities including IQ, OQ, PQ, and/or TMV.
• Familiarity with statistical analysis and problem-solving methodologies such as Six Sigma, Root Cause Analysis, 5-Why, and Fishbone Analysis.
• Demonstrated ability to solve technical problems using structured engineering approaches.
• Strong organizational skills with the ability to manage multiple priorities.
• Effective written and verbal communication skills.
• Ability to work independently while collaborating effectively within cross-functional teams.
• Positive attitude, strong work ethic, and commitment to delivering results in a fast-paced manufacturing environment.

Qualifications

• Working knowledge and hands-on experience in one or more of the following manufacturing and process technologies: cleanroom assembly of miniature and precision medical device components, laser welding processes, resistance welding processes, injection molding processes, silicone molding processes, sterile packaging technologies, process development and process optimization methodologies, statistical analysis and process characterization techniques, Medical Device Design Control requirements and documentation, Risk management principles and Design for Manufacturability (DFM), Validation methodologies including IQ, OQ, PQ, and TMV.

Skills

• Support of Integer's Manufacturing Excellence and Market Focused Innovation Strategies.
• Active support of the deployment of systems, tools, and best practices that drive innovation and continuous improvement.
• Participation in Manufacturing Excellence initiatives based on the Integer Production System.
• Contribution to workplace organization, visual management, standardized work, and problem-solving activities.
• Support of process optimization and waste reduction initiatives using Lean and Six Sigma principles.
• Participation in cross-functional efforts to improve safety, quality, delivery, and cost performance.
• Contribute ideas and solutions that improve manufacturing capability, process robustness, and customer satisfaction.

Benefits

Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success. Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy. We provide a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits. Parental leave is available after one year. Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance. Employees are immediately eligible to participate in the 401(k) plan with company matching contributions. We provide 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.