Additional Locations: (n/a)

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 purpose—improving lives through your life’s work.

About This Role:

This Quality Engineer role will investigate product complaints for the Electrophysiology (EP) division of Rhythm Management. The team uses complaint and physical product analysis data to inform cross-functional division of potential safety and quality issues with BSC EP products. This role provides significant visibility across the quality organization. 

Your Responsibilities Will Include:

• Assumes technical role in functional area by using technical expertise and knowledge to support current and new market released technology 
• Assists Senior level engineers in projects to enhance the ability to perform various complaint Investigations
• Maintains knowledge of state-of-the-art principles and strategies in their particular area of expertise
• Participates in technical strategy planning for Boston Scientific
• Assists lab technicians during complaint/analysis investigaitons to ensure accurate and compliant product analysis and documentation 
• May be asked to engage in projects/project plans outlining work plans including timelines, roles and resources; Identifies and leads cross-functional project team comprised of functional experts and local managers
• Analyze returned products to address complaints and to ensure a high level of product quality
• Communicate product quality issues to Senior Engineers and/or Management for awareness to cross functional areas including Research and Development, Supplier Quality and Manufacturing
• Participate in cross functional teams to resolve quality issues
• Interpret complex technical issues for a non-technical audience
• Provide techical support for regulatory and legal inquiries
• Assist in developing novel methods to effectively analyze product complaints
• Performs a variety of duties in the electrical, mechanical, electro-mechanical, chemical, or optical areas

What We're Looking For In You:

Minimum Qualifications

• BS with 0-3 years of relevant experience
• Understanding and a command of highly technical engineering and mathematic topics
• Ability to independently manage project work to define delivery dates
• Understanding and experience operating within quality system processes and procedures.  
• A successful track record of cross organizational project collaboration
• Significant participation in the Hazard Analysis and Risk Assessment as related to trend management
• Strengths in communication (verbal and written) and data analysis skills

Preferred Qualifications

• Engineering degree with 1-3 years of relevant experience
• A strong technical understanding of device therapy products
• Strong Technical Writing skills
• Experience with the Quality system escalation process including NCEP initiation and escalation into the CAPA and PIR processes. 
• Strong understanding of the Quality system and post-market complaint tracking, patterning and analysis
• Project experience and/or collaboration with Medical Safety, Design Assurance, Return Product Analysis, Supplier Development and Manufacturing
• Ability to work with or independently learn automation tools such as Automation Anywhere is highly desirable.
• Experience supporting competent authority responses

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 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: 476829