Product Development Engineer II

integer; Plymouth (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

Integer Holdings Corporation in Minnesota seeks an engineer to apply advanced engineering principles across concept to manufacturing of medical devices. You will design, develop, and validate new products and processes while coordinating with other departments to meet timelines.

You will review drawings, test procedures, and documentation, ensure compliance with QMS and FDA regulations, and contribute to process improvements.

Qualifications

• Apply engineering principles in broad areas of assignments and related fields.
• Coordinate design engineering activities with other departments.
• Review, initiate or approve engineering drawings, layouts, changes orders and specifications.
• Plan process flow and evaluate process capability.
• Develop and review test procedures and plans, conduct failure analysis.
• Adhere to Quality Management Systems (QMS), safety and regulatory requirements (FDA).
• Collaborate with others, communicate clearly and regularly check for understanding.

Responsibilities

• Initiate, direct and manage design and development of new products and processes from concept to commercial manufacturing.
• Plan, schedule and coordinate detailed phases of engineering work on major projects or smaller scope projects.
• Develop testing procedures and perform failure analysis on products, processes and materials.
• Review procedures and plans prior to implementation and evaluate existing products for improvements.
• Apply standard data analysis to establish root cause for failures and justify improvements.
• Follow Integer's QMS and production system methodologies and ensure regulatory compliance.
• Collaborate across departments to ensure customer expectations are met or exceeded.

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.

• 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 apply intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields. Ensures Integer internal and external customers' expectations are met or exceeded. 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.

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

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