Process Development Engineer II

About this 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 Holdings Corporation (NYSE: ITGR) is one of the largest medical device contract development and manufacturing organizations (CDMOs) in the world, serving the cardio and vascular, neuromodulation, and cardiac rhythm management markets. As a strategic partner of choice, we advance the goals of our medical device customers through industry-leading engineering and manufacturing, with a relentless commitment to quality, service, and innovation. The company's brands include Greatbatch Medical® and Lake Region Medical®.

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. Develops processes and equipment to introduce new products into manufacturing sites with the goal to ensure safe, high-quality and cost-effective results. Identifies existing or develops new process and equipment technology, characterizes and optimizes processes, and validates processes and manufacturing lines. As part of a broader new product introduction team, establishes efficient production line layouts or leads process improvements to existing plant operations. May perform estimations of production times, staffing requirements, and/or related costs. • 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.

• You will review procedures and plans prior to implementation as well as evaluate existing products, processes and materials for failure analysis and potential improvements.

• You will participate in projects that require you to investigate, develop, document and implement new product and process technologies of moderate complexity and scope. 

• While often you may be responding to situations presented to you by others, you will also be able to demonstrate proactive insight into technical challenges and mitigates potential issues or incorporates improvements.

• You will plan, schedule and execute the engineering work in a part of a major project; or you may lead a  smaller scope project.

• You will perform work on technical projects where you will follow Integer’s standard quality management and production system methodologies to investigate opportunities for product and process improvements.

• You will apply standard data analysis practices and techniques to establish root cause for product and process failures or to support the justification for improvements to products and processes.

• You will be required to observe products and processes to recognize discrepancies in results and follow operations throughout a series of detailed steps or processes to establish root cause of the discrepancies.

• You are expected to collaborate with others in the exchange of information, ask questions and regularly check for understanding in support of your development as an engineer.

• You embed Quality within the Engineering discipline – “I own Quality.”  You are a standard bearer for Quality in everything we do at Integer, by assuring adherence to our Quality Management System (QMS), facilitating and/or contributing to corrective and preventive actions, and contributing to the successful attainment of our quality KPI’s and journey to 5 Sigma.

• You may perform other duties as needed and as directed by your line of supervision.

Provide support of Integer’s Manufacturing Excellence and Market Focused Innovation Strategies • You champion the development of and deployment of the systems and tools to drive innovation and continuous improvement.

• You embrace the Manufacturing Excellence culture based on the Integer Production System and its five focus areas: • Strategy Alignment through Site Hoshin Plans, the regular cadence of Sales, Inventory, and Operations’ Planning (SiOP) meetings, and regular updates to the value stream maps.

• Leadership of Sustained Change by ensuring production monitoring & improvement activities and deployment of Leader Standard Work.

• Standardization through workplace organization & visual controls (5S), Manufacturing Standard Work, and robust training & certification programs.

• Associate Engagement promoted through the adoption of standardized problem solving. methodologies, behavior-based safety programs, and improvement idea and suggestion systems.

• Systems & Process Optimization through adoption of principles of built in quality, optimized scheduling & material system designs, work cell design, and total productive maintenance.

How you will be measured:   The specific measures listed below may be su

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