Principal R&D Engineering - Exploratory

Position Overview:

The Engineer 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 with development of balloon catheters (i.e., PTA, PTCA) cardiovascular medical devices is required.

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.
• 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.

Qualifications:

Education:

• BS degree in Engineering, Biomedical or Physics

1. Minimum Required Experience:

• Minimum of 15 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.

Preferred Experience

• 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 results‐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