Additional Locations: Costa Rica-Heredia
Purpose and Passion Comprehensive Benefits Life-Work Integration Community Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purposeimproving lives through your life's work.
About the role:
The Senior Design Assurance Engineer will identify resources, lead cross-functional teams, assess status, and drive timely root cause identification and corrective action development to help improve the performance of BSC market-released electrophysiology systems, pacemakers, defibrillators, lead systems, and programmers/patient-monitoring systems. This position is exposed to multiple departments across the organization and is suitable for individuals with a natural technical curiosity and leadership aspirations.
This individual will provide Engineering support to design and development, helping to ensure delivery of highest quality product to the customer. Provide Corrective and Preventive Action Engineering support to ensure highest quality of Quality System documentation.
Your responsibilities include:
Responsible for leading cross-functional meetings to identify resources, assess status, and drive timely root cause identification and corrective action development for BSC fielded CRM and EP products and systems. This includes deriving validation or verification plans, implementation strategies, and effectiveness reviews.
Provides status updates to various management forums.
Works with owners of existing systems to collects and analyze product performance data to support Corrective and Preventive Action activity.
Creates Quality Tools & Training Materials by applying body of knowledge/expertise and communicating to respective teams.
Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation. Could serve as auditor of areas of the BSC quality system, such as development and manufacturing, as assigned.
Evaluate, review, and approve Quality System records related to nonconforming events or corrective actions.
What we're looking for:
BS in Engineering or science field and 5-8+ years of relevant Quality Engineering experience OR Master's degree with 3-6+ years of relevant experience
Medical Device industry experience
Strong working knowledge of Microsoft Word, PowerPoint, and Excel
High level of attention to detail and compliance
Ability to effectively support multiple high priority deliverables at once
Solid written and verbal communication skills.
Creative and innovative thinking
Strong analytical skills
Demonstrated experience managing multiple projects covering diverse engineering disciplines (examples: Software, Hardware, Labeling).
Prior interactions with the following disciplines: CAPA, risk management, post market complaints
Must be comfortable speaking to groups of individuals. Presentation skills that comfortably and concisely translate field performance to peer and senior management audiences.
Knowledgeable of statistical theory and application.
Project Management skills
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you're looking to truly make a difference to people both around the world and around the corner, there's no better place to make it happen.
Boston Scientific is an Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
Requisition ID: 449270