Process Development Engineer III

Integer•Plymouth, MN

18d•$96,000 - $141,000

About The Position

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. The Engineer III ensures that Integer's internal and external customer expectations are met or exceeded through effective engineering practices, quality compliance, and continuous improvement. You adhere to Integer's Values and all safety, environmental, security, and quality requirements including, but not limited to, Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, FDA regulations, company policies, operating procedures, and other applicable regulatory requirements. You support process development activities for new product introduction, product transfers, and process improvement initiatives. You execute engineering projects and assignments under the guidance of Project Managers and Senior Engineers while independently managing assigned workstreams and deliverables. You may serve as the primary technical lead for selected projects of limited to moderate complexity. You develop and optimize manufacturing processes to achieve safety, quality, delivery, and cost objectives. You participate in process characterization activities and utilize data-driven methods to establish robust manufacturing processes. You support and execute process validation activities including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Test Method Validation (TMV). You develop, review, and maintain technical documentation including protocols, reports, work instructions, specifications, engineering studies, and validation documents. You investigate manufacturing issues, perform root cause analysis, and implement corrective and preventive actions. You collaborate with cross-functional teams including Quality, Manufacturing, Operations, Supply Chain, R&D, and Regulatory Affairs to achieve project objectives. You support equipment selection, qualification, and implementation activities as required. You develop and maintain effective working relationships with internal and external stakeholders. You contribute to continuous improvement initiatives that improve product quality, process capability, productivity, and operational efficiency. You perform other duties as assigned by management. Technical Competencies The Engineer III is expected to possess 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. Provide Support of Integer's Manufacturing Excellence and Market Focused Innovation Strategies You actively support the deployment of systems, tools, and best practices that drive innovation and continuous improvement. You participate in Manufacturing Excellence initiatives based on the Integer Production System. You contribute to workplace organization, visual management, standardized work, and problem-solving activities. You support process optimization and waste reduction initiatives using Lean and Six Sigma principles. You participate in cross-functional efforts to improve safety, quality, delivery, and cost performance. You contribute ideas and solutions that improve manufacturing capability, process robustness, and customer satisfaction. How you will be measured The specific measures listed below may be subject to change and are not intended to be an all-inclusive list. Safety performance and active participation in Environmental Health & Safety programs. Achievement of project objectives, milestones, and deliverables. Quality performance and adherence to applicable QMS and regulatory requirements. Successful execution of process development, characterization, and validation activities. Timely completion and quality of engineering documentation. Process improvements resulting in enhanced quality, efficiency, capacity, or cost savings. Effective collaboration with cross-functional teams and internal customers. Contributions to innovation, continuous improvement, and operational excellence initiatives.

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.

Nice To Haves

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.

Responsibilities

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.
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.
Actively support the deployment of systems, tools, and best practices that drive innovation and continuous improvement.
Participate in Manufacturing Excellence initiatives based on the Integer Production System.
Contribute to workplace organization, visual management, standardized work, and problem-solving activities.
Support process optimization and waste reduction initiatives using Lean and Six Sigma principles.
Participate 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.
Perform other duties as assigned by management.