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
Design Assurance Engineer
Job Summary
The primary purpose of this position is to support new product development activities to ensure that the desired design performance is achieved meeting the applicable medical device FDA regulatory requirements and the company’s Policies & Procedures.
The Design Assurance Engineer will ensure a successful transfer of the newly developed product to production while supporting design concept phases through launch.
Key Accountabilities and Responsibilities
1. Adheres 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.
2. 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.
3. Assists in the preparation of related project deliverables, such as design verification and design validation protocols and reports; and process validation protocols and reports.
4. Participates in risk assessment and mitigation activities (FMEA, FTA, etc.) in support of new product development.
5. Supports Product Development Manufacturing Engineering in developing test fixtures/ test methodology, developing production acceptance criteria and test methods.
6. Participates in the preparation of Quality Plans, including inspection and gauge requirements.
7. Provides support for root cause analyses, CAPA, and Distributed Product Risk Assessment and updates SOPs as required.
8. Supports sourced item qualification activities and supports supplier risk management initiatives.
9. Assists in the testing and validation of new test methods, including R&R studies of the measurement system and statistical analysis of data through software packages such as Minitab.
10. Performs other functions as required
U.S. Applicants: EOE/AA Disability/Veteran
Top Skills
What We Do
Integer Holdings Corporation (NYSE:ITGR) is a leader in advanced medical device outsourcing (MDO) and serves its customers by providing comprehensive end-to-end solutions with its unparalleled expertise in innovation and manufacturing. Integer's vision is to enhance the lives of patients worldwide by being its customer's partner of choice for innovative medical technologies and services. Additionally, through Electrochem, an Integer company, it develops custom batteries for high-end niche applications in energy, military, and environment markets. The company's medical device manufacturing brands include Greatbatch™ Medical and Lake Region Medical™. Additional information is available at www.integer.net.
