Engineer II - Manufacturing

Integer Holdings Corporation • Quakertown, PA

10d

About The Position

The Engineer II - Manufacturing performs general engineering work using established methods and tools, with opportunities to apply more advanced technologies and concepts while developing in the medical device industry. With occasional direction from experienced engineers and managers, the role works to meet or exceed internal and external customer expectations and initiates, directs, and manages development of products and processes from concept through commercial manufacturing. The engineer coordinates design activities across departments; reviews, initiates, or approves engineering drawings, layouts, change orders, and specifications; plans process flow; evaluates process capability; and designs, builds, or modifies tooling. The position also plans and executes engineering work within larger projects or leads smaller projects, develops and reviews test plans and procedures, performs failure analysis and inspections, and prepares project documentation.

The role supports ongoing production as a primary technical resource for production lines, working with production associates to resolve process and equipment issues. It develops and implements process and equipment solutions to improve safety, quality, delivery, and cost; develops and procures manufacturing tooling, fixtures, and equipment; and creates and maintains manufacturing documents and digital operations systems. The engineer leads equipment qualification and process validation tasks, supports product and process changes and transfers, and collaborates with manufacturing, quality, supply chain, and R&D teams on manufacturability, improvement, nonconforming products, and new products or processes.

The engineer follows Integer’s values and applicable safety, environmental, security, quality, FDA, company, and other regulatory requirements. The position embeds quality in engineering work, supports corrective and preventive actions and quality goals, uses data analysis to identify root causes and justify improvements, and contributes to Manufacturing Excellence and continuous improvement initiatives. The role generally works independently with occasional guidance, while regularly collaborating and checking for understanding. Other duties may be assigned as directed by supervision.

Requirements

• Bachelor’s degree in engineering or a related technical field, at minimum, with at least three years of relevant experience; candidates not meeting the education requirement may be considered with 7 or more years of relevant experience.
• Ability to work independently and collaboratively with associates and cross-functional teams.
• Solid technical aptitude and ability to contribute effectively to a team or produce technical results individually.
• Functional understanding of Integer Quality Management Systems and ability to complete required quality-system documentation with little or no direction.
• Competent written and oral communication skills.
• Ability to maintain a calm demeanor in a high-energy, constantly changing production environment.
• Positive, can-do attitude and belief that failure is not an option.

Responsibilities

• Initiate, direct, and manage design and development of products and processes from concept through commercial manufacturing.
• Coordinate design engineering activities with other departments and review, initiate, or approve engineering drawings, layouts, change orders, and specifications.
• Plan process flows, evaluate process capability, and design, build, or modify tooling.
• Plan, schedule, and execute engineering work as part of a major project or lead a smaller-scope project.
• Develop and/or review test plans and procedures, and conduct failure analysis and inspections of products, processes, and materials.
• Investigate, document, and implement product and process technologies and improvements of moderate complexity and scope.
• Support production operations as a primary technical resource for production lines, resolving process and equipment issues with production associates.
• Develop and implement process and equipment solutions to improve safety, quality, delivery, and cost on existing production lines.
• Develop and procure tooling, fixtures, and equipment that optimize productivity, maintainability, and cost.
• Create and maintain manufacturing documents and digital operations systems, including drawings, bills of materials, routers, work instructions, engineering change orders, and MES configuration models.
• Lead equipment qualification and process validation tasks.
• Collaborate with cross-functional teams to evaluate designs for manufacturability, cost reduction, and business growth.
• Identify process improvement opportunities and evaluate or disposition nonconforming products as needed.
• Establish and execute corrective and preventive action plans to address quality or operational concerns and mitigate production failures.
• Monitor equipment, machines, and tools; correct equipment problems or process parameters contributing to nonconforming products, low yields, or quality issues.
• Interface with Quality and R&D to integrate new products or processes and correct manufacturing nonconformances identified during prototype builds.
• Support complaint investigations and the DPRA process; own CAPAs related to product design.
• Lead design transfer activities with manufacturing sites and support design- or process-related changes and supplier changes that could affect product design.
• Follow Integer’s quality, safety, environmental, security, FDA, company, and other applicable regulatory requirements.
• Use standard data analysis techniques and observe products and processes to establish root causes of failures or discrepancies and support improvement justifications.
• Contribute to Quality Management System adherence, corrective and preventive actions, quality KPIs, and the site’s quality goals.
• Support Manufacturing Excellence, innovation, and continuous improvement systems and tools.
• Generate continuous improvement suggestions and support their implementation.
• Perform other duties as needed and directed by the line of supervision.

Benefits

• Comprehensive benefits package with immediate eligibility, including medical, dental, vision, disability, and life insurance.
• Adoption benefits.
• Parental leave available after one year.
• Optional employee-paid supplemental life insurance, critical illness, hospital indemnity, and accident insurance.
• Immediate eligibility for the 401(k) plan with company matching contributions.
• 80 hours (10 days) of company-designated holidays per year.
• Annual allotment of paid time off.
• Base salary and a cash-based incentive program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level