Design Quality Engineer I

Additional Location(s): N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance

At Boston Scientific well give you the opportunity to harness all thats within you by working in teams of diverse and high-performing employees tackling some of the most important health industry challenges. With access to the latest tools information and training well help you in advancing your skills and career. Here youll be supported in progressing whatever your ambitions.

About this role

The 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 NCEPs CAPAs 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 coop or projectbased 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 problemsolving methodologies such as DMAIC 5 Whys or other rootcause tools.

Requisition ID:636092

Minimum 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 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.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years we advance science for life byprovidinga broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular respiratory digestive oncologicalneurologicaland urological diseases and conditions. Learn more atand follow us onLinkedIn.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy the Company will continue to take steps to assure that recruitment hiring assignment promotion compensation and all other personnel decisions are made and administered without regard to race religion color national origin citizenship sex sexual orientation gender identity gender expression veteran status age mental or physical disability genetic information or any other protected class.

Please be advised that certain US based positions including without limitation field sales and service positions that call on hospitals and/or health care centers require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company you will be expected to meet the ongoing requirements for your roles including any new requirements should the Companys policies or protocols change with regard to COVID-19 vaccination.

Among other requirements Boston Scientific maintains specificprohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and as such candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.