Design Assurance Engineer III - Electrophysiology

Design Assurance Engineer III

At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing – whatever your ambitions.

About the role:

We have an exciting opportunity for a Design Assurance Engineer III supporting new product development and sustaining activities for the cardiac mapping and ablation systems within the EP division. This position supports several product categories with high visibility which will provide the right candidate with excellent growth potential, commercial experience, and perspective in the medical device industry. The Design Assurance Engineer III will work with a high-performance cross-functional team to ensure safety, quality, and compliance of products to deliver the highest quality product to the customer.

Work Mode

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office three days per week.

Your responsibilities include:

• Work cross-functionally with R&D, project management, manufacturing, regulatory, clinical and marketing to ensure project success.
• Leads/supports the determination and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
• Maintains product risk management documentation (i.e. Hazard Analysis & FMEAs).
• Leads/supports the development of and coordinates the execution and documentation of Design Validation and Verification activities.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Supports and leads the execution and investigation of CAPAs, NCEP, Complaints, Failure Mode Investigations, etc.
• Demonstrate good working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards.
• Able to navigate gray space by applying risk-based criteria to prioritize project work.
• Support cross functional team through product life cycle process; specifically, with respect to design control and risk management deliverables.

Required Qualifications:

• Minimum of a bachelor's degree in Materials, Mechanical, Electrical, Chemical, Biotechnology, Electromechanical or related field of study
• Minimum 4 years of experience in Quality Assurance and/or Design Assurance, Sustaining, R&D, Manufacturing or related medical device experience
• ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
• Experience navigating design, manufacturing and/or supplier variations

Preferred Qualifications:

• Strong understanding of NCEP/CAPA processes
• Previous experience working to create/maintain risk documentation such as FMEAs and HAs
• Experience working with Stature or FMEA MED-8 software
• Self-motivated with a passion for solving problems and a bias for action
• Ability to manage multiple priorities and work with ambiguity
• Strong communication skills (verbal & written)
• Proficiency in collaborating with interdisciplinary teams
• Familiar with EP environment