Product Development Engineer III

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

Job summary

Integer Holdings Corporation in Minnesota (Plymouth) seeks an experienced design engineer to lead the design and development of new medical devices from concept through commercial manufacturing. You will collaborate with R&D, manufacturing, and quality to ensure robust designs, documentation, and compliance.

The role emphasizes applying engineering principles, reviewing drawings, planning tooling, and developing testing procedures while upholding QMS, FDA regulations, and company standards.

Qualifications

• Apply intensive and diversified knowledge of engineering principles to broad assignments and related fields.
• Reviews, initiates or approves engineering drawings, layouts, changes orders and specifications.
• Plans process flow and evaluates process capability across projects.
• Develops and reviews test procedures and plans prior to implementation.

Responsibilities

• Initiate and manage design and development of new products from concept to manufacturing.
• Coordinate with other departments to schedule and execute engineering work on major projects.
• Ensure compliance with QMS, FDA regulations, and company policies.
• Prepare documentation for projects, protocols, and reports as needed.
• Lead cross-functional teams or projects with limited resources and risk.
• Mentor or guide peers to deploy expertise across organizations.

Skills

Engineering principles

Design development

Project coordination

Problem solving

Cross-functional collaboration

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.

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 develop new and unique approaches to challenging problems and work on projects that advance Integer's technological capabilities.

You will investigate and interpret internal or external technology and business trends and recommend best practices to the organization.

You will evaluate, develop and implement a wide range of new technologies of moderate scope and complexity.

You may identify and procure the new equipment and technology of moderate complexity, scope and cost.

You will originate new documents such as protocols, reports, specifications and work-instructions; and you may also review documentation work product of peers and others.

You will plan and develop engineering projects concerned with unique problems or team challenges, which have an important impact on moderate to large programs.

You may lead cross-functional teams or projects with minimal resource requirements, risk and or complexity and may begin developing the skills to influence others to achieve goals.

You will initiate and maintain relationships with individuals and business units within your site or organization.

You will be proficient in specialty areas or technologies and are building advanced skills to become a subject matter expert. As a result, you may be directed to deploy your expertise across multiple organizations and/or locations. As a result, occasional travel may be required in this position.

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 Syste m (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 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 up