Quality Engineer I - Design Assurance Job

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. Want to know more about what it’s like to work at Boston Scientific? Our “Day in the Life” Zoom series offers an opportunity to interact with employees who are collaborating for change. Copy and paste this link into your browser to sign up: https://bit.ly/bscdayinthelife .

Apply your skills and experience to ensure patient safety by joining the Design Assurance quality team at Boston Scientific. Thrive in a culture that prioritizes learning and development, build lasting relationships with colleagues, and truly make a difference to people around the world and around the corner.

A career with Boston Scientific is more than just a job. As a leader in medical science, we are committed to solving the challenges that matter most. If you’re a natural problem-solver with the imagination, courage and spirit to make a meaningful difference, there’s no better place to build your career.

With more than three decades of global leadership in the medical device industry, our mission is to transform the lives of patients worldwide by advancing science. With determination, imagination and a deep passion for human life, we’re exceeding the boundaries of what was previously thought possible.

About the Role:

The Quality Engineer I - Design Assurance is a quality engineering role that will support new product development and design changes to commercialized products to improve the delivery of care for customers and patients around the world. This role will work with small, high-performance development teams to establish and maintain project deliverables, assess and manage risk, and maintain compliance for Interventional Cardiology products. This role will provide quality engineering support to design requirements, product verification and validation, risk management, design change control, and ongoing product design support.

Key Responsibilities:

• Apply sound, systematic problem-solving methodologies to balance quality requirements with business needs.
• Work on a cross-functional team with partners in marketing, regulatory, legal, supplier management and product development to identify and implement effective design controls and support product development from concept through commercialization.
• Lead the development, implementation and updates of product safety risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
• Leads the development of and coordinate the execution and documentation of Design Validation and Verification activities.
• Perform regulatory standard assessments and support regulatory submissions to notified bodies.
• Demonstrate good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards.
• Establish and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).
• Mentor cross functional team through product development process; specifically, with respect to design control and risk management deliverables.

Minimum Qualifications:

• Bachelor’s degree in Biomedical, Mechanical, Chemical or Electrical Engineering or related fields
• 0-2 years of related work experience
• Flexible and positive attitude, team-oriented
• Good communication skills (verbal and written), comfortable speaking and presenting to others
• Strong analytical skills
• Comfortable working independently and as part of a cross-functional team
• Ability to manage multiple priorities and work with ambiguity

Preferred Qualifications:

• Experience working in a regulated industry
• Previous design assurance or R&D experience in medical device industry
• ISO 13485, ISO 14971 and Quality System Regulations knowledge

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

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:474169