Principal R&D Engineer, Exploratory

Boston Scientific•Carlsbad, CA

29d•$103,700 - $197,000•Onsite

About The Position

Boston Scientific is looking for a Principal R&D Engineer. This person will be a key contributor for early-stage medical device development (Exploratory Programs). The Engineer will work closely with a small team to create and explore new ideas to solve unmet medical device needs. The ideal candidate will possess deep knowledge across a wide span of cardiovascular therapies, catheters, and accessories used in cases. Experience in the development of balloon catheters (i.e., PTA, PTCA) cardiovascular medical devices is required.

Requirements

BS degree in Engineering, Biomedical or Physics.
Minimum of 8 years of experience in medical device engineering.
Proven track record of developing medical devices from concept to design transfer that have made it to market.
Generated core IP and patents related to commercial medical devices.
Proficient in CAD software, preferably SolidWorks.
Experience with mechanical and/or electrical design, mechanical/electrical drawings, tolerance analysis, and computer-aided design (CAD).
Excellent hands-on mechanical prototyping, verification, and failure analysis skills.
Proven self-starter who runs towards critical issues, ambiguous requirements, or loosely defined challenges with a demonstrated ability to rally teams to achieve business results.

Nice To Haves

MS/PHD in Engineering, Biomedical or Physics.
Polymer knowledge along with extrusion, injection molding experience and metallurgy.
Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD.
Working knowledge of mechanical design principles.
Experience developing FDA class 3 medical devices.
Medical Device experience in new product development with successful design from concept to commercialization is strongly preferred.
Familiarity with statistical analysis of raw data is required, proficiency in Minitab is preferred.
Knowledge of ASME Y14.5 GD&T.
A flexible team player, focusing on shared goals with a positive resultsâ oriented attitude.
Strong leadership skills and mentoring capabilities
Strong interpersonal and communication skills (oral/presentation and written.
Strong quantitative analysis and problem-solving skills and methodologies.

Responsibilities

Utilize research and experience to develop new technologies to improve therapies of medical devices.
Manage multiple projects simultaneously, on time, well documented and within budget to meet business objectives.
Work independently to develop high value IP to solve unmet medical device needs for existing or new therapies.
Collaborate with external suppliers for components and identify outsourcing opportunities to accelerate early development cycles.
Understand the technology and key product features that ensure clinical and commercial success.
Manage research and development activities for exploratory phase of a project.
Make data driven decisions using appropriate analytical methodologies.
Prepare for and conduct various exploratory concept reviews.
Demonstrate deep insight regarding design intent and use insight to drive value added early-stage design ideas.
Working with highly skilled technicians, develop processes necessary to fabricate devices.
Develop and implement new test methods to assess performance characteristics of designs.
Prepare documentation to support design transfer for early development teams. (IP, concept documents, test results, drawings, etc.)
Provide technical leadership along with technical subject matter expertise to technology development team during exploratory design transfer.
Research and recommend material choices for product designs.
Translate highly technical results into easily understood recommendations that will influence cross-functional and senior stakeholders.