Engineer II - Manufacturing

What you’ll do in this role

The primary purpose of this position is to perform work which involves general engineering methods and tools; but you may also utilize more advanced technologies and engineering concepts while you are developing in your role as an engineer in the medical device industry. In this role, you will ensure that Integer’s internal and external customer expectations are met or exceeded with occasional direction, instruction and guidance from more experienced engineers and managers in your organization.

• Initiates, directs and manages the design, and development of new products and processes from concept to commercial manufacturing.
• Works closely with other departments to coordinate design engineering activities.
• Reviews, initiates or approves engineering drawings, layouts, changes orders and specifications.
• Plans process flow, evaluates process capability, modifies tooling, builds tooling, and designs tooling.
• Plans, schedules, conducts or coordinates detailed phases of the engineering work in a part of a major project.
• Develops and/or reviews test procedures and plans prior to implementation, as well as conduct failure analysis and inspection on products, processes and materials.
• Evaluates, selects, and applies standard engineering techniques and procedures while using judgment when making minor adaptations and modifications.
• Devises new approaches to problems encountered.
• Prepares all necessary paperwork and documentation for all projects undertaken.

Specialization

• Supports ongoing production operations and is the primary technical support resource for production lines.
• Typically, works directly with production associates daily to support process and equipment as well as responds to resolve technical issues that arise during production operations.
• Develops, details, and implements process and equipment solutions which improve safety, quality, delivery and cost on existing production lines.
• Develops and procures tooling, fixtures, and equipment used in manufacturing that optimize productivity, maintainability, and cost.
• Creates and maintains manufacturing documents and digital operations systems (IIOT systems) including engineering drawings, BOMs, routers, process work instructions, engineering change orders, and MES configuration modeling.
• Leads equipment qualification and process validation tasks.
• Collaborates with cross-functional teams to evaluate and influence designs for manufacturability, cost reduction and business growth projects.
• Interacts with manufacturing, quality and supply chain associates to identify process improvement opportunities and to evaluate/disposition non-conforming products as needed.
• Establishes and executes corrective and preventative action plans to remediate system quality or operational concerns and proactively takes action to mitigate potential for production operations failures.
• Participate in cross-functional project teams to implement creative solutions.
• Monitors performance of equipment, machines and tools and correct equipment problems or process parameters that produce non-conforming products, low yields or product quality issues.
• Interfaces with Quality and R&D to integrate new products or processes.
• Responsible for identifying and correcting manufacturing process nonconformance’s identified during prototype builds.
• Works with the product monitoring group on complaint investigations and supports the DPRA process.
• CAPA owner for any CAPA’s related to the design of the product.
• Coordinates with the manufacturing site on product transfers by leading the design transfer process.
• Supports the manufacturing site on any design or process related changes.
• Supports the supplier quality team on for supplier changes that might impact the product design.

What sets you apart

• You earned, as a minimum, a bachelor’s degree in an engineering or related technical field; and have at least three years of relevant experience.
• Candidates who do not meet the education requirement may be considered with 7+ years of relevant experience.
• While you will have occasional support and guidance from more experienced engineers, supervisors or managers, you will demonstrate the ability to work independently as well as collaboratively with other associates and cross functional teams.
• You demonstrate a solid technical aptitude with the ability to be an effective contributor to a team or produce results of a technical nature as an individual.
• You have a functional understanding of the Integer Quality Management Systems and are able to complete required Quality System documentation tasks with little or no direction from others.
• You demonstrate competency in both written and oral communications.
• You maintain a calm demeanor that transcends the high energy, constantly changing production environment.
• You possess a positive, can-do attitude with an underlying belief that failure is not an option.