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.
Key Accountabilities and Responsibilities
- 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.
- As a quality Core Team member, plays a key role on development project teams. Performs quality/reliability engineering activities while providing guidance and expert advice to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled.
- Leads Risk Management (ISO 14971) and Usability program activities. Leads cross function teams in planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations. Maintains risk management file for the life of the device.
- Generates and/or reviews and provides guidance for related project deliverables, such as design verification and design validation protocols and reports as well as process validation protocols and reports. Works cross functionally with R&D and provides expert guidance in the review of technical documentation.
- Leads and provides guidance with Product Development Manufacturing Engineering in development of test, develop production acceptance criteria, test methods, and process validation protocols.
- Leads and provides guidance for 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. Is the SME for standards interpretation and statistical methods.
- Leads and provide guidance for root cause analyses investigations, preparation of CAPA and Distributed Product Risk Assessment. Draft and update SOPs as required.
- Performs other functions as required.
Job Requirements
Minimum Education: Bachelor’s Degree in Engineering or related field required. Master’s Degree preferred.
Minimum Experience: 7-10 years of experience.
Specialized Knowledge:
- Practical knowledge of FDA Quality System Regulations, ISO 13485 and Medical Device Directive.
- Practical knowledge of ISO 14971 and related standards
- 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).
- Proficient in establishing and implementing quality metrics for product development.
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
- May travel up to 10%
