The primary purpose of this job is to manage engineering functions. Identify and evaluate procedures and process equipment required to produce a quality product.
Integer is hiring for a Sr. Design Assurance Engineer supporting our Cardio & Vascular group. The ideal candidate would have strong experience in Test Design, Development and Validation, strong project management skills, and have experience working in a regulated industry environment.
Accountabilities & Responsibilities:
- Design and maintain product assurance programs to effectively develop and approve new product.
- Plan and delegate to Design Engineering staff in order to accomplish project goals.
- Provide leadership to achieve a better design process, more efficient design reviews, and improved design challenge testing. Lead early avoidance of potential design defects.
- Prepare validations, verifications, risk analysis and similar product assurance activities.
- Prepare, review and analyze design history documents to assure technical accuracy, completeness and compliance with applicable internal, regulatory and customer guidelines. Ensure accurate and complete design records are maintained.
- Work with regulatory affairs staff to prepare regulatory submissions and reports to FDA, ISO, PMDA and other regulatory authorities.
- Compile and prepare technical information for customer distribution.
- Communicate with customers and product users to define product performance and safety requirements. Evaluate and respond to customer complaints and concerns on new and pilot products.
- Provide Quality/Design Assurance engineering support for pilot, pre-production and production lines.
- Participate in product development projects as a primary team member. Educate team personnel on policy and practice on a continuous basis.
- Represent the Product Assurance engineering department at planning and other management meetings in absence of the manager; act as a liaison between management and subordinates to keep personnel informed on technical matters, decisions and policies.
- Keep informed of developed pertaining to inspection techniques, tooling, and training that would be of assistance to Integer or production departments. Actively participate in making recommendations for improvements.
- Interview and participate in Quality/Design Assurance personnel selection as required.
- Apply continuous improvement/lean concepts to identify and eliminate non-value added tasks and/or other activities
- Perform other duties as assigned.
Education & Experience:
- Bachelor's degree in related Engineering field. Masters degree preferred.
- Minimum 7+ years of experience in a Design Assurance / Quality discipline
- Medical Device experience preferred