Diversity - Innovation - Caring - General Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's 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, we'll help you in advancing your skills and career.

About the Role Boston Scientific is seeking a Senior Design Quality Assurance (DQA) Manager to lead the Design Quality team supporting Neuromodulation Deep Brain Stimulation (DBS) and Spinal Cord Stimulation (SCS) systems. This role is responsible for ensuring product quality, patient safety, and regulatory compliance through the application of Design Controls and Risk Management principles across the product lifecycle. The Senior DQA Manager will lead a team supporting implantable pulse generators (IPGs), external trial systems (ETS), batteries, leads, accessories, chargers, controllers, and related technologies.

The position serves as a key quality partner to Research & Development, Regulatory Affairs, Clinical, Manufacturing, and Post-Market Surveillance teams, supporting new product development, sustaining engineering, remediation activities, CAPAs, and regulatory commitments.

At Boston

Scientific, we value collaboration and synergy. This hybrid role is based in Valencia, CA and requires being on-site at least three days per week.

Relocation assistance: Relocation assistance is 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. Lead, mentor,



and develop a high-performing Design Quality Assurance team. Provide quality leadership for new product development, design changes, and sustaining engineering activities.

Ensure effective implementation of Design Controls, Risk Management, and Quality System requirements. Drive compliance with FDA regulations, ISO 13485, ISO 14971, and applicable global standards. Partner cross-functionally to resolve complex quality, compliance, and product performance issues.

Influence technical decisions through risk-based and patient-focused quality principles.

Required Qualifications Bachelors degree in Engineering, Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or a related technical discipline. Minimum 10 years of experience in the medical device or other regulated industry. Strong knowledge of Design Controls, Risk Management, and Quality Systems.

Experience with FDA Quality System Regulations, ISO 13485, and ISO 14971.

Electrical

Engineering degree preferred.

Experience supporting implantable or active implantable medical devices.

Experience with neuromodulation systems, implantable pulse generators, batteries, power systems, and software-enabled medical devices.

Experience leading global or multi-site technical teams.





Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements). For MA positions It is unlawful to require or administer a lie detector test for employment. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare.

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. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test 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. #

📌 Senior Design Quality Assurance Manager - Neuromodulation (Valencia)
🏢 Boston Scientific
📍 Valencia