The primary purpose of this job is to support new product development to ensure that the desired design performance is achieved meeting the applicable medical device FDA/European regulatory requirements and companies Policies & Procedures. The Design Assurance Engineer will ensure a successful transfer of newly developed product to production, while supporting design phases concept through launch on to sustaining practice related to company owned product families.
This role is a unique opportunity to be involved in the development of products and process for medical components through finished medical devices. This person will be directly involved in tasks to support product development that involves direct communication with suppliers, customers and team members. This person must be able to use their expertise to work quickly to solve problems. In addition to the above, this person:
1. Adheres to Integer values 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. Is the quality department Core Team member where they perform engineering activities to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled according to their procedures. This person builds consensus where appropriate.
3. Leads Risk Management (ISO 14971) activities which includes a cross functional team for the planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations for each product or process. Maintains risk management file for the life of the products they are responsible for.
4. Generates and/or reviews related project deliverables such as: design verification and design validation protocols and reports as well as process verification and process validation protocols and reports. This person will coordinate these with the R&D team in the review of technical documentation.
5. Works with Product Development Engineering teams in the development and qualification of test methods including fixture, acceptance criteria and test methodology development.
6. Coordinates sourced item qualification activities and supports supplier risk management initiatives. Conducts Independent review of DHF and Technical files, provides technical standards interpretation, and determines appropriate statistical methods, including sample size determination.
7. Provides support in conducting root cause analyses, preparation of CAPA, complaints and Distributed Product Risk Assessment. Draft and update SOPs as required.
8. Provides quality support for products for which they are developing including writing First Article Inspections, Certificates of Conformance and Non-conforming material reviews.
9. Performs other functions as required.
Job Requirements Minimum Education:
Bachelor's Degree in Engineering or related field required. Master's Degree preferred.
5-7 years of experience.
Practical knowledge of FDA Quality System Regulations, ISO 13485 and European Medical Device Directive.
Practical knowledge of ISO 14971, and related standards
General familiarity with industry best practices in development, testing and manufacturing processes.
Experience in interpreting design schematics and drawings.
Preferred experience with FDA and European regulated medical devices
Skilled in statistical methods e.g. ANOVA, SPC, test sample size selection plans, Gauge R&R, and DOE.
Demonstrated proficiency utilizing quality lean sigma tools (e.g. Root Cause Analysis, QFD, Ishikawa, Kepner-Tregoe).
Experience in establishing and implementing quality metrics for product development.
Strong collaboration, negotiation, and conflict resolution skills.
Excellent verbal and written communication skills..
Excellent technical writing.