The primary purpose of this job is to 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.
Key Accountabilities and Responsibilities
1. Adheres to Integer Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
2. Drives development of test design and development, from initial fixture and method development to final validation, including hands on method development. Provides input to team members on methodology and best practices.
4. Generates and/or reviews and provides guidance for related project deliverables, such as equipment drawings or models, qualifications, and test method validations.
5. Leads and provides guidance with Product Development Engineering in development of test, develop production acceptance criteria, test methods, and process validation protocols.
7. Leads and provides guidance for root cause analyses investigations.
8. Executes testing in support of method validations or characterization of methods
Bachelor's Degree in Engineering or related field required. Master's Degree preferred.
3-6 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.