Job Description

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, were solving some of the most important healthcare industry challenges. Together, were one global team committed to making a difference in peoples lives around the world. This is a place where you can find a career with meaningful purposeimproving lives through your lifes work.

Principal Engineer, CRM Design Assurance

The Principal Design Assurance Engineer will lead cross functional teams to determine actionable root cause and implement effective solutions for issues impacting commercial Cardiac Rhythm Management (CRM) product performance. This role is a great fit for an individual who has, or is seeking, leadership and problem solving experience, with an innate technical curiosity. This individual will collaborate and partner with Research & Development, Regulatory, Marketing, Medical Safety, Manufacturing, and Quality to achieve optimal results. May serve as liaison between the company and the various governmental agencies worldwide.

Responsibilities:

* Leads product performance investigations, where suspected root cause is product design, including Nonconforming Events and Preventions (NCEPs), Product Inquiry Reports (PIRs), and Corrective and Preventive Actions (CAPAs). This includes recruiting cross-functional teams, leading cross-functional team meetings, and driving efficient and effective problem solving (includes root cause identification, solution development/recommendation, solution implementation strategy development/support, and solution effectiveness verification). Presents updates in formal and informal reviews with all levels of the organization.
* Creates, maintains, and enhances cross-functional team relationships. Provides guidance regarding technical strategies and approaches; works cross-functionally and across multiple sites in identifying and resolving technical issues.
* Creates, reviews, and approves Quality System records for NCEPs, PIRs, and CAPAs. May represent NCEPs, PIRs, and CAPAs in internal and external audits.
* Fosters a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
* Monitors and ensures compliance with company policies and procedures.

Minimum Qualifications:

* BS with 9-13+ years of experience or MS with 7-11+ years of experience
* Regulated industry experience
* Ability to effectively support multiple high priority deliverables in parallel
* Ability to communicate and lead across functions and sites
* Strong written and verbal communication skills
* Demonstrated detail orientation
* Demonstrated problem solving skills
* Proficient use of Microsoft Word, PowerPoint, and Excel

Preferred Qualifications:

* Medical Device industry experience
* Experience with NCEP, PIR, and/or CAPA
* Excellent written and verbal communication skills
* Project Management and/or Technical Leadership experience
* Experience leading projects across functions and across sites
* Demonstrated ability to lead teams through complex technical problem solving using disciplined, methodical techniques
* Exemplifies high performance expectations, proactively influences the organization in positive directions, and inspires engagement and commitment from others to achieve common goals
* Demonstrated ability to effectively present complicated technical information to small and large audiences, from peers to senior leadership, with varying levels of technical expertise
* Experience with statistics and statistical analysis tools (e.g. MINITAB, Weibull++)

About us

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 youre looking to truly make a difference to people both around the world and around the corner, theres 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

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Requisition ID: 475633