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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.
About the role:
The Design Assurance Engineer is a trusted partner to Marketing, Operations, Research & Development, Regulatory, and Program Management in transforming lives through innovative medical solutions that improve the health of patients around the world. You are expert in the potential failure mechanisms that affect our products, and in the engineering controls that mitigate those failure mechanisms. You generate new knowledge to make Boston Scientific products better.
You serve on a high-performing cross-functional product development team to design world class Electrophysiology (EP) Systems and EP Catheters that drive corporate growth. This high visibility position provides the right candidate with excellent growth potential. Together with our partners, you create and maintain a healthy work environment where all stakeholders are treated with respect, where open communication builds relationships of trust, where decisions are made with data, where excellence in engineering practice is valued, and where everyone can do their best work.
Your responsibilities include:
Prepare, review, and approve design change assessments, design verification test protocols, design verification test reports, and engineering change notices for new products and changes to existing products.
Mine customer experience data from the post-market quality system to quantify field performance of complex EP Systems and to relate engineering controls (design inputs, design outputs, and preventions) to the failure mechanisms they are intended to mitigate.
Use Design Failure Modes and Effects Analysis (DFMEA) to organize the overall design program and to drive engineering effort toward meaningful product quality improvement.
Prepare, review, and approve post market surveillance plans and periodic safety update reports in conformance with the European Union Medical Device Regulation (EUMDR)
This position is intended to develop high-potential engineers to serve as technical leads, engineering fellows, field clinical engineers, functional managers, and other senior technical roles for future product development programs. Demonstrated accountability for results and a strong commitment to professional development are essential for this position.
Strong interpersonal skills and the ability to interact with physicians in the clinical setting are essential. The successful candidate will be comfortable and effective working in the hospital EP lab, the manufacturing floor, and the engineering test lab.
This position is based in Arden Hills, MN, USA
What we're looking for in you:
Bachelor of Science degree in Biomedical Engineering, Mechanical Engineering , Electrical Engineering, or a related field of study with 5-9 years of experience in product design, design assurance, or manufacturing process development of high technology products.
Alternatively, Master of Science degree in an Biomedical Engineering, Mechanical Engineering , Electrical Engineering, or related field of study with 3-7 years of experience.
Hands-on approach to problem solving
Strong communication skills
Demonstrated use of quantitative engineering tools for design optimization.
Experience developing complex engineering systems.
Travel as required (10%).
Experience developing medical systems.
Experience developing EP Systems and EP Catheters.
ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
Experience with Automotive engineering, especially DFMEA
Experience working in the hospital environment or GLP laboratory.
Exceptional candidates with a BS degree and more than 9 years of experience or an MS degree and more than 7 years of experience will be considered for a Principal Engineer level position.
Exceptional candidates with a BS degree and 2-5 years of experience or an MS degree and 0-3 years of experience will be considered for an Engineer II level position.
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: 453659