Additional Location(s): US-MA-Marlborough; N/A
About this role:The Principal Design Quality Assurance Engineer is a seasoned professional with experience in quality engineering and regulatory requirements for the medical device industry. This role serves as a driving force in the quality department, championing excellence, compliance, and continuous improvement across projects and teams. The position is part of the design site for the Endoscopy Division and supports activities such as New Product Development, Sustaining and Life Cycle Management, and Quality Systems initiatives related to design and development.
Work mode:At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Marlborough, MA and requires being on-site at least three days per week.
Relocation assistance:Relocation assistance may be 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: - Acts as the primary voice for quality within cross-functional teams, influencing project direction and ensuring adherence to regulatory requirements and best practices.
- Leads the execution of Quality Deliverables such as Project Design & Development Plan, Field Assessment Plan, Design Change, and Design & Usability Validation Plans. Leads the execution of the Risk Management deliverables to ensure compliance to ISO 14971 and demonstrates a primary commitment to patient safety. Guides the successful completion of major programs and may function in a project leadership role.
- Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units. May lead specialized technical project teams which have a broad impact on the company utilizing cross-functional resources. Acts as division representative on cross-divisional projects defining the quality system(s).
- Leverages deep technical knowledge to lead teams through complex problem-solving initiatives. Applies systematic approaches (e.g. 5 Whys, Is-Is Not, DMAIC and Six Sigma problem solving methodologies) to diagnose root causes, optimize processes, and ensure sustained corrective actions.
- Guides and mentors engineers, fostering a culture of learning, collaboration, and technical excellence. Provides coaching on quality engineering methodologies and problem-solving techniques.
- Establishes strong relationships across departments, effectively communicating quality priorities, presenting findings, and driving consensus among stakeholders. Uses influence and negotiation skills to integrate quality perspectives into business decisions.
- Identifies and implements best-in-class practices for the department. Proactively assesses opportunities for improvements or enhancement to quality systems and processes in the company.
- Supports internal and external regulatory audits as audit facing subject matter expert as required. Supports regulatory responses through technical writing and submission consultation as required.
What we're looking for in you: Required Qualifications
- BS in Biomedical Engineering, Mechanical Engineering or related degree.
- 8+ years of medical device engineering experience.
- In-depth knowledge of US and International medical device requirements including 21 CFR part 820, Medical Device Directive (MDD) / Medical Device Regulation (EU MDR), EN ISO 13485 and EN ISO 14971.
- Travel approximately 10-20%.
Preferred Qualifications
- 10+ years of medical device engineering experience.
- Expertise in Usability and Human Factors engineering.
- Proficiency in Minitab Statistical Analysis software or equivalent.
- Six Sigma Black Belt Certification.
Requisition ID: 631837 Minimum Salary: $ 97000 Maximum Salary: $ 184300 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.
