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 position is to perform work mainly in the Design Assurance Laboratory, which involves general engineering methods and tools. As an entry level engineer, 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.
Key Accountabilities and Responsibilities
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.
As a quality Core Team member, actively participates in development project teams. Performs quality/reliability engineering activities to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled.
Generates and execute validation protocols and reports (IEQ, PQ, TMV, SWIQ) for design verification test methods.
Support DA lab staff during design verification and design validation protocols execution (test).
Collaborates with DA, R&D, and NPI teams to develop, validate, and implement test methods. Leads efforts in fixture design, test method qualification, and creation of clear, accurate work instructions.
Drive and support continuous improvement initiatives for legacy test methods.
Performs other functions as required.
Specialized Knowledge
Knowledge of statistical techniques and data analysis.
Root cause investigation and problem solving.
Understanding of quality systems and regulated environments.
Basic data analysis and graphing tools.
Familiarity with laboratory equipment and measurement tools.