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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 purposeimproving lives through your life's work.
Quality Engineer II - Design Assurance -Peripheral Interventions
About the role:
The Design Assurance Engineer provides EU MDR support with high visibility which will provide the right candidate with excellent growth potential. Work with high-performance cross-functional sustaining team to ensure safety, quality and compliance of launched products while continuously improving their commercial value through end-of-life. Products transferred to SE include internally developed products, Sourced Finished Medical Devices and acquired products. SE Design Assurance engineer works in close partnership with Research and Development and focuses on protecting the design intent of a product to meet safety, efficacy, regulatory, and business requirements.
Your responsibilities include:
Actively promote and participate in a cross-functional teamwork environment.
Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed
Maintains product risk management documentation (i.e. Hazard Analysis, Fault Tree, FMEAs).
Supports product Post Market activities such assessment of risk based on post market signals, field assessments, and post market surveillance plans and reports
Leads/supports the determination and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
Leads the development of and coordinate the execution and documentation of Design Validation and Verification activities.
Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Demonstrate good working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards.
Perform regulatory standard assessments and support regulatory submissions to notified bodies.
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
What we're looking for:
Bachelor's degree in an Engineering discipline or related field of study
2+ years of experience in design assurance, new product development or related medical device / regulated industry experience
Self-motivated with a passion for solving problems and a bias for action
Hands-on approach to product development
Strong communication skills (verbal & written)
Demonstrated use of Quality tools/methodologies
ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
Travel as required (10%)
Previous development of complex medical device system experience
Experience interfacing with physicians to gather insight into new product concepts and associated risk
Previous experience with developing capital equipment as a medical device
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: 451796