Additional Location(s): N/A
About the roleThe Senior Design Quality Assurance Engineer serves as a key Quality representative for the design, development, integration, and sustaining support of Neuromodulation medical-device systems. The role emphasizes external equipment, implantable leads, accessories, and surgical tools.
This engineer partners with R&D, Systems Engineering, Manufacturing, Supplier Engineering, Regulatory Affairs, Clinical, Human Factors, and Project Management to build quality into products throughout the product life cycle. The position provides independent quality oversight of design controls, risk management, design verification and validation, design transfer, change assessment, and post-market feedback.
This is a defined-term, hybrid position preferably based in Valencia, California (or California in general), with periodic on-site presence aligned to business and project needs.
Work mode:At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Valencia or Carlsbad, CA and requires being on-site at least three (3) 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 will include- Serve as the Design Quality Assurance representative for new-product development, integration, remediation, and sustaining projects involving implantable leads, accessories, and surgical tools.
- Support cross-functional teams through applicable design-control activities, ensuring user needs, design inputs, design outputs, design reviews, verification, validation, design transfer, and design changes are appropriately planned, executed, documented, and traceable.
- Provide quality oversight for risk-management activities throughout the product life cycle, including risk-management planning, preliminary hazard analysis, system and component hazard analyses, design FMEAs, use-related risk analysis, risk-control verification, residual-risk evaluation, and production/post-production feedback.
- Support design validation and human-factors activities to confirm that the finished device, accessories, labeling, packaging, and use workflows meet user needs and intended uses in representative use environments.
- Providing quality oversight for biocompatibility, sterilization, packaging, shelf-life, transport, electrical safety, electromagnetic compatibility, and active-implantable-device evidence, as applicable to the assigned products and changes.
- Support supplier and manufacturing quality activities that affect design requirements or product performance, including component qualification, supplier changes, nonconformance investigations, process validation, design transfer, and production-readiness reviews.
- Lead or support design-change assessments, CAPA, complaint investigations, nonconformance investigations, and field-signal evaluations by connecting post-market evidence to risk files, requirements, verification evidence, and potential corrective actions.
- Lead and support the review of post-market surveillance data, to evaluate product performance, identify emerging risks and trends, assess potential impacts to design requirements and risk management files, and determine the need for design, labeling, verification, validation, or corrective actions.
- Facilitate monthly Complaint Review Board (CRB) activities, including coordinating cross-functional contributors to develop meeting content, supporting pre-read review of clinical and medical safety escalation assessments, analyzing and trending complaint data, tracking and following up on action items, summarizing CRB decisions and outcomes, and distributing meeting materials and follow-up actions to stakeholders and participants.
What we're looking for in you:Required qualifications
- Bachelor's degree in biomedical, Mechanical, Electrical, Materials, Systems, Manufacturing Engineering, or another relevant engineering or scientific discipline.
- Minimum of 5 years of experience in Design Quality, Quality Engineering, Quality Systems, Post-Market Surveillance, Risk Management, CAPA, product development, or a related engineering function in the medical-device industry or another highly regulated environment.
- Experience reviewing technical documentation such as engineering drawings, specifications, tolerance analyses, test protocols/reports, FMEAs, hazard analyses, and validation evidence.
- Ability to apply risk-based judgment, independently challenge incomplete evidence, and translate quality and regulatory expectations into actionable project requirements.
- Clear written and verbal communication skills and the ability to collaborate effectively across R&D, Manufacturing, Supplier Engineering, Regulatory, Clinical, Human Factors, Marketing, and Project Management.
- Working knowledge of U.S. FDA Quality Management System Regulation and applicable design-control, complaint, CAPA, and reporting requirements, as well as applicable international regulatory requirements.
- Experience with ISO 13485, Medical devices quality management systems.
- Experience with ISO 14971, Medical-device risk management.
Preferred qualifications
- Master's degree in engineering, scientific, or quality-related discipline.
- Direct experience with active implantable neuromodulation devices and associated external equipment, implantable leads, extensions, accessories, chargers, or surgical tools.
- Experience with lead and connector performance, mechanical fatigue, electrical integrity, biocompatibility, sterilization, packaging, shelf life, and simulated-use testing.
- Experience planning or reviewing Design Verification, Design Validation, reliability, test-method validation, Gauge R&R, and statistical sample-size rationales.
- Experience with supplier controls, component qualification, manufacturing transfer, process validation, complaint handling, CAPA, and external or regulatory audits.
- Experience supporting system-level risk management and traceability across multiple hardware subsystems and interfaces.
- Experience with IEC 62366-1, application of usability engineering to medical devices.
- Experience with IEC 60601-1, basic safety and essential performance of medical electrical equipment.
- ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Six Sigma certification, or comparable quality credential.
Requisition ID: 634783Minimum Salary: $ 89200 Maximum Salary: $ 169500 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.
