Design Assurance Engineer I

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 role is to support the Design Assurance group in areas including Design verification, design Validation, statistics, risk management. test method development and standards, sourced item qualification, test method validation, design input requirements (spec generation), ensuring design outputs meets inputs, design transfer support, process validation support for Integer owned products. DA supports process development projects. As an entry level associate, you will ensure that Integer’s internal and external customer expectations are met or exceeded with the direction, instruction and guidance from more experienced engineers and managers in your organization. You will learn the application of design assurance and product test development and testing concepts in the design & manufacture of Integers product lines.

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.

• Under the supervision of experienced Design Assurance mentors and managers, you will select and apply standard engineering techniques and applicable procedures, to provide support in the aspects outlined below.

Design Assurance Activities

• Under supervision, you will assist in the development of new test methods and in the improvement of existing methods including design and manufacture of new tooling, fixtures, and templates.
• Assist in the testing and validation of new test methods including gage R&R studies and statistical analysis of data through software packages such as Minitab.
• Update test method procedures and design assurance standard operating procedures as required.
• Provide technical input into root cause analysis. Generate investigation reports within KPI metrics and timelines and route for approval. Participate and provide technical input on cross functional reviews of open field and customer returns.
• You will review procedures, protocols, reports, and other documents related to design assurance, test method development, product development and product testing and product validation which may be associated with new product development and introduction.

• You will be a member of a Cross Functional Project Team, providing design assurance support and expertise for the development of new products through R&D/NPI.Participate and provide technical input in line with the product development process (PDP) and associated procedures.

• Ensure compliance at all stages of product development process (PDP).
• Support planning execution of design verification & validation activities.

• Support planning execution of risk management activities per ISO14971.

• Operate and carry out product testing as required to support process and design validation, product development, or in supporting investigations of customer returns or complaints.
• Under supervision, carry out periodic reviews of internal and external standards and identify potential gaps which require action.
• Ensure compliance of integer owned devices to state-of-the-art regulatory standards which DA are assigned.
• You are expected to collaborate with o…