Additional Location(s): N/A
About this roleThe Design Quality Engineer I will be part of the Endoscopy Access and Patency franchise supporting sustaining for Self Expanding Stents (SES) manufactured at the Galway site. The Design Quality Engineer I will develop, establish and maintain quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. This engineer will serve as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.
This position is part of the design site for the Endoscopy Division which supports New Product Development, Sustaining Engineering, and Life Cycle Management initiatives.
Work Mode:At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.
Relocation Assistance:Relocation assistance is not available for this position at this time.
Visa Sponsorship:Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Your responsibilities include- Develop an understanding of Design Controls, Risk Management and Usability for Medical Devices
- Provide quality and compliance input to cross-functional project teams, ensuring activities follow regulatory requirements and internal quality procedures.
- Apply basic problem-solving tools (e.g., 5 Whys, Is/Is Not) with mentorship to support identifying, prioritizing, communicating, and resolving quality issues.
- Contribute to ongoing improvements within quality and/or business processes by identifying opportunities to streamline documentation, processes, or tools.
- Develop working relationships across departments and assist in communicating quality priorities and findings.
- Support internal and external regulatory audits as required.
- Provide quality and compliance input for post market product sustaining activities, such as design changes, supplier auditing and surveillance, design concessions, product CE marking and safety certification, customer complaint investigations, NCEP's, CAPA's and Field Signals.
Required Qualifications- Minimum of a Bachelors degree in Biomedical Engineering, Mechanical Engineering, or related technical field.
- Minimum of less than one year of experience.
- Travel approximately 10%
Preferred Qualifications- Strong communication, collaboration, and documentation skills.
- Internship, co-op, or project-based experience in engineering, quality, or medical devices.
- Foundational understanding of design controls, risk management, and regulated product development.
- Familiarity with basic statistical analysis tools; coursework in Minitab or PowerBI is a plus.
- Exposure to problem-solving methodologies such as DMAIC, 5 Whys, or other root-cause tools.
Requisition ID: 636092Minimum Salary: $ 62800 Maximum Salary: $ 119300 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.
At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.Compensation for
non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation for
exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
