Process Development Engineer III

Integer Holdings Corporation; Plymouth (MN); On-site; USD 96,000 - 141,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) with company match

Parental leave

Paid holidays

Adoption benefits

Job summary

Integer Holdings Corporation in Plymouth, MN, seeks an Engineer III to apply engineering knowledge to support process development, manufacturing, and product realization. You will lead workstreams and act as the primary technical lead on selected projects, ensuring quality, safety, and regulatory compliance.

The role requires 5–8 years in medical device manufacturing, with experience in cleanroom assembly, laser and resistance welding, injection and silicone molding, and sterile packaging.

Qualifications

• Bachelor's degree in Engineering or a related technical field.
• 5–8 years of engineering experience in medical device manufacturing.
• Hands-on experience with cleanroom assembly and related technologies.
• Familiarity with IQ/OQ/PQ and TMV validation activities.
• Strong analytical and problem-solving skills and familiarity with Six Sigma tools.

Responsibilities

• Support process development activities for new product introduction and transfers.
• Execute process characterization studies and validation activities (IQ/OQ/PQ/TMV).
• Investigate manufacturing issues, perform root cause analysis, and implement CAPAs.
• Collaborate with Quality, Manufacturing, R&D, Regulatory, and Supply Chain teams.

Skills

Cleanroom assembly

Laser welding

Resistance welding

Injection molding

Silicone molding

Sterile packaging

Statistical analysis

Design Controls

TMV (Test Method Validation)

Six Sigma/Root Cause Analysis

Education

Bachelor's degree in Engineering

Tools

QMS

Job description

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.At Integer, our values are embedded in everything we do.CustomerWe focus on our customers’ successInnovationWe create better solutionsCollaborationWe create success togetherInclusionWe always interact with others respectfullyCandorWe are open and honest with one anotherIntegrityWe do the right things and do things rightThe 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 CompetenciesThe 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 StrategiesYou 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 measuredThe 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.What sets you apartBachelor'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.Salary: 96,000-141,000Our 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.U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.