Location: Heredia, Heredia (CR:H), Costa Rica (CR)
Additional Locations:
Hiring Manager: Daniel J Cooke
Recruiter: Raul Gallardo Sunol
Design Assurance Engineer II
About the role:
The Design Assurance Engineer is a trusted partner to Marketing, Operations, Research and 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:
Learn, use, and teach the most effective engineering tools to optimize product designs: Hazard Analysis, Fault Tree Analysis, Exploratory Data Analysis, Voice of the Customer, Benchmarking, Human Factors Engineering, Numerical Simulation, Design of Experiments, Design Limit Output Evaluation, Design Input Overstress Testing, HALT, Tolerance Stack Up Analysis, and ad hoc Testing. This position is a technical, engineering job.
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 Heredia, Costa Rica
What were looking for in you:
Minimum qualifications:
* 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 a
