Manufacturing Engineer II
Integer Holdings CorporationAbout the role
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.
Customer
We focus on our customers’ success
Innovation
We create better solutions
Collaboration
We create success together
Inclusion
We always interact with others respectfully
Candor
We are open and honest with one another
Integrity
We do the right things and do things right
Who are we?
Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEM’s (original equipment manufacturers) to enhance the lives of patients worldwide and a provider of high-end niche batteries for specialized applications in the energy, military, and environmental markets. We are guided by our six Values, including focus on Customers, Innovation, Collaboration, Inclusion, Candor, and Integrity. Working at Integer means you are part of a team passionately pursuing excellence in all that we do and always reaching for the next great achievement.
What you’ll do in this role:
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.
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.
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, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
You will generally work independently with occasional guidance from supervisors or mentors to evaluate, select and apply standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications to existing specifications, procedures, and work instructions.
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