The primary purpose of this position is to perform work which involves conventional engineering practice. Ensures Integer's internal and external customer expectations are met or exceeded. Will support, through test development, new product development and continuation activities to ensure that the desired design performance is achieved meeting the applicable medical device FDA/European regulatory requirements and companies Policies & Procedures. The Test Design Engineer will ensure a successful transfer of newly developed product to production, while supporting design phases concept through launch.Supports test function for system hardware, software, and test data manipulation projects. Provides accurate estimations and reports of all test processes.
* 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.
* Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications.
* Performs work which involves conventional types of plans, investigations, surveys, structures, or equipment.
* Applies standard practices and techniques in specific situations, adjusts and correlates data.
* Recognizes discrepancies in results and follows operations through a series of related detailed steps or processes.
* Reviews test procedures and plans prior to implementation, conducts failure analysis and inspection on products, processes and materials.
* Investigates, develops and implements new process technologies of moderate scope.
* Performs other duties as required.
Education: Minimum Education: Bachelor's degree in a related field
* Minimum Experience: 0-3 years of experience
- Practical knowledge of FDA Quality System Regulations Medical Device Directive.
- General familiarity with industry best practices in development, testing and manufacturing processes. Medical device sterilization process.
- Experience in interpreting design schematics and design drawings.
- Preferred experience with FDA and European regulated medical devices
- Demonstrated proficiency in statistical methods e.g. ANOVA, SPC, test sample size plans, Gauge R&R, and DOE.
- Demonstrated proficiency utilizing quality lean sigma tools (e.g. Root Cause Analysis, QFD, Ishikawa, Kepner-Tregoe).
- Special Skills: Strong collaboration, negotiation, and conflict resolution skills.
- Ability to lead team activities and coach.
- Excellent communication, presentation, follow through and organizational skills, verbal and written communication skills to be applied at all levels of the organization.
- Excellent technical writing skill
Other: Up to 10% travel.