Additional Location(s): N/A
About the RoleBoston 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.
Work mode: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.
Your responsibilities will include:- 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.
- Support CAPAs, NCEPs, product inquiries, complaint investigations, and remediation initiatives.
- Lead inspection readiness efforts and support internal, external, and regulatory audits.
- Establish organizational priorities, resource plans, and workload strategies.
- Influence technical decisions through risk-based and patient-focused quality principles.
- Foster a culture of accountability, continuous improvement, and technical excellence.
What we're look for in you:Required Qualifications
- Bachelor's 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.
- Minimum 5 years of direct people leadership experience.
- Strong knowledge of Design Controls, Risk Management, and Quality Systems.
- Experience with FDA Quality System Regulations, ISO 13485, and ISO 14971.
- Demonstrated ability to influence and collaborate across functions.
- Excellent written and verbal communication skills.
Preferred Qualifications
- Advanced degree in Engineering.
- 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 FDA remediation, CAPA, NCEP, and inspection readiness activities.
- Experience leading global or multi-site technical teams.
Requisition ID: 632730Minimum Salary: $ 131700 Maximum Salary: $ 250200 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.
