Sr Design Assurance Engineer - 13999

Job Description: General Summary: The Senior Design Assurance Quality Engineer provides focused quality engineering support within new product development and sustaining engineering of Urological medical devices. This work includes the use and application of design control methods, risk analysis, test method development, statistical analysis, complaint analysis, as well as support of product CE Mark and Shonin recertification activities.

Additionally, the Candidate will be responsible for oversight of the Urology Analytical Lab providing technical direction and Quality Assurance support per part 211 requirements.

Individual must possess high attention to detail, problem solving skills, knowledge of regulations and standards. Excellent written and verbal communication skills are essential. Individual must be able to communicate and interact with all levels of staff.

Duties and Responsibilities:
- Active member of project teams ensuring Design Assurance requirements are met.
- Monitor complaints and provide feedback and recommendations for corrective action.
- Support Quality requirements for sustaining engineering projects.
- Reviews and actively ensures policies and SOPs are followed. May interface with
internal/external audits and reviews.
- Provides guidance and training to analytical lab staff.
- Ensures quality and integrity of analytical lab data.

Job Experience:
Qualifications:

5+ Years experience with BS in Quality Engineering or related discipline, in the medical device industry with analytical lab experience. Exposure to the pharmaceutical or combination medical device industry a plus. Strong written/verbal communication skills. Demonstrated use of Quality tools/methodologies, including design controls and statistical analysis. Experience driving GMP, ICH, and Part 211 compliance. Solid knowledge of QSR and MDD requirements.

Searchable Keywords: Sr Design Assurance Engineer - 13999 / gj-mo

Minimum Education Required: Bachelor

Years of Experience Required: More than 5 years

Expected Travel Time: None

This company may offer relocation assistance.


Boston Scientific offers incredible opportunities to grow and advance, a dynamic work environment and an excellent benefits package. Boston Scientific is an equal opportunity employer, M/F/D/V.