NPI Quality Engineer III

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:

The primary purpose of this job is to apply intensive and diversified knowledge of engineering principles and practices to New Product Introduction (NPI) projects. The following are expectations:

* Ensure Integer internal and external customer expectations are met or exceeded. You Identify and evaluate procedures to ensure the production of quality product.

* Develop new and unique approaches to complex problems and can advance technology beyond previous achieved levels.

* Apply engineering concepts to resolve acute or chronic problems.

* Conduct studies to understand capability for process and/or measurement systems. Provides management with technical guidance as required.

* Identify and develop appropriate documentation for process improvement and project implementation.

* Maintain liaison with individuals and units within or outside the organization with responsibility for acting independently on technical matters pertaining to their field.

* 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.

NPI Support:

* You will support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.

* You will develop new test methods including design and manufacture of new tooling, fixtures, and templates.

* Carry out 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 process 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 NPI team reviews.

* You will review procedures, protocols, reports, and other documents related to test method development, process testing and process validation which may be associated with new product introduction.

* Lead a Cross Functional Project Team, providing support and expertise for 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 risk management activities per ISO
14971.

* Carry out periodic reviews of internal and external standards and identify potential gaps which require action.

* You will lead continuous improvement projects.

* You will assist with product transfers.

* 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 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.

Create Test Methods:

* You will lead the generation and completion of protocols and reports for test method validations.

* You will interface with Manufacturing Engineers to review processes for new products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.

* You will develop various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.

Support Non-Conforming Material Process:

* You will ensure that the disposition of non-conforming materials meets all necessary…