Additional Locations: US-MA-Marlborough

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 position will provide focused quality engineering leadership supporting the Endoscopy and Urology & Pelvic Health divisions to bring state of the art technical expertise and practices across multiple Complaint Investigation Sites (CIS) within the Post Market Quality function.  The person in this role will develop and refine failure analysis methodologies as a means of advancing comprehensive understanding of product performance to improve patient outcomes. They will act as a liaison between the CIS and key partners in R&D, Design Assurance, Supplier Engineering, and Manufacturing to find solutions to our product issues and opportunities for improvement.  The person in this role should possess demonstrated ability to work in a cross-functional problem-solving capacity.

Your Responsibilities Will Include:

• Lead overarching development of methodologies and practices that will evolve the team’s overall capabilities over time
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Provide key technical support to the Complaint Investigation team (CIS) for the in-depth analysis of returned complaint devices
• Provide project direction, technical coaching, and mentoring for engineering and technical team personnel.
• Drive collaborations with cross-functional partners in R&D, Sustaining, Design Assurance, Ops QA and Supplier QA to improve failure characterization of returned products
• Identify and implement effective product analysis protocols (methodologies and equipment) to support comprehensive failure analysis
• Ensure comprehensive understanding of expected failure modes for products investigated at each site as captured in risk documentation
• Develop and implement BSC-wide CIS strategy, based on core competencies and product type
• Participate in acquisition integrations teams, serving as primary CIS SME to
  • Learn acquisition products (intended use, clinical performance, risk assessments)
  • Evaluate acquired company’s returned product testing methodologies, processes and staff competencies
  • Determine appropriate BSC CIS site to assume failure analysis responsibilities
  • Work with receiving BSC CIS site leadership to successfully integrate
• Participate in site / divisional complaint review board forums, representing CIS Failure Analysis outcomes
• Collaborate with GCMS Product Team to ensure system functionality and codes support improved failure analysis outcomes
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• 25-50% travel required

What We’re Looking For In you:

Minimum Requirements

• Engineering degree
• Strong understanding of overall Quality System Requirements, with focus on Complaint Handling, CAPA, Design Controls and Risk Management
• 10+ years failure analysis experience
• 5+ years management or equivalent leadership experience
• Strong written and verbal communication skills
• Strong technical writing skills

Preferred Requirements

• Advanced degree (MS preferred/Mechanical Engineering strongly preferred / Medical device experience strongly preferred)
• Manufacturing Engineering / problem solving discipline

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: 439922