Job Description
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
- 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