Company: DEKA RESEARCH & DEVELOPMENT
Job Type: Permanent, FullTime
DEKA Research and Development, housed in Manchester, NH, has an exciting opportunity for a Quality Engineering Manager to work in a dynamic Medical Device R&D environment. This unique opportunity has high visibility within the company and plays a vital role in the success of our products. This is a great opportunity to utilize your solid technical capabilities and leadership skills to guide a quality and test team for products that truly make a difference. Interested? We'd love to hear from you.
How will you make an impact?
- Lead and mentor a team of Quality Engineers, Test Engineers and Technicians to build comprehensive test suites to verify functionality of breakthrough medical products
- Partner with Project Managers, System Engineers, and other technical leads to plan and execute on project goals
- Develop robust risk management plans, test plans, strategies, and reports
- Help define product requirements to ensure products are complete and testable
- Assess test impacts for design changes and approve design changes
- Ensure manufacturing quality for engineering, verification and clinical trial builds
- Participate and contribute towards Regulatory and Agency submissions
- Facilitate design control compliance, design transfer plans and sustaining engineering quality support
To be successful in this role, you will need the following skills and experience:
- BS degree in Physics, Electrical, Mechanical, and/or Biomedical Engineering
- Minimum 7 years of Quality/Test Engineering experience in an R&D environment for an electrical-mechanical device (medical preferred)
- The capability to create and clearly explain team objectives and write procedures for others to follow
- Demonstrated ability to problem solve with a deep understanding of engineering fundamentals
- The knack for motivating a team and ability to estimate team effort and create predictable schedules
- Broad measurement instrument knowledge and experience with data analysis
- Knowledge of FDA's Quality System Regulations (QSR's) and/or ISO 13485 and ISO14971
One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research and Development, where we are taking the same innovation and cutting-edge technology into the modern age.
Behind DEKA's brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.
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