Sr Quality Engineer - 14674

Job Description: This position will support the integration of an OEM capital equipment product within the BSC Urology division. As a key member of the product integration team, the Sr. Quality Engineer will provide design assurance direction in the areas of risk management, DFMEA, test method validation, specification/sample plan criteria, design verification/validation, process validation and DHF organization/content Review OEM documentation to verify alignment of the marketing/product specifications and ensure overall compliance of product design controls in accordance with company policies, procedures and regulatory requirements. Develop, refine and document program quality plans. Identify critical performance features and work closely with supply chain, operations and supplier quality personnel to ensure adequacy of related process controls. This includes inspection instructions, test method development/validation, periodic control testing and sampling plan selection. Assist in the development of a technical file including essential requirements, design verification, biocompatibility, packaging, labeling and risk management overviews.

Must work well as a member of a highly interactive and dynamic team and possess excellent organizational and communications skills.

Job Experience:
Qualifications and experience shall include:

* Bachelors degree in Engineering
* Minimum of 8 years experience with Medical Devices
* Knowledge of ISO 13485 and QSR regulatory requirements relating to Design Control
* Design verification and validation testing
* IEC 60601 test requirements
* Demonstrated statistical skills (CQE, CRE) and/or training in Six Sigma.

Experience in the following areas is highly desired:

* Software controlled medical equipment
* PMA/class 3 products
* Electro-mechanical medical products
* OEM partnerships
* EU, CE and MDD requirements

Supervisory experience is a plus.

Searchable Keywords: Sr Quality Engineer - 14674 / 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.