About the Role

As the Sr. Catheter Development Engineer, you’ll be responsible for the technical development and process validation activities of the catheter platform that delivers pulsatile pressure waves that treat calcific arterial and valve disease.

We are looking for a highly motivated, dedicated and enthusiastic medical device developer whose responsibilities will include:

Concept development from early prototypes to concept freeze
Verification and validation of prespecified design requirements and parameters
Development and validation of catheter processes
Developing and maintaining comprehensive design documentation
Maintaining close ties with vendors.
Improving supply chain and ensuring new suppliers are meeting the prespecified quality and design metrics.

In this role, you will assume some project management responsibilities, including ensuring the objective and the scope of the project are well defined, and leading project or sub-project meetings.

You will make an impact by:

Designing and developing high-volume medical devices that can be manufactured via extruding, braiding, laminating, bonding, injection molding, stamping, etching, laser cutting/welding, ultrasonic welding, etc.
Prototyping and testing concepts for feasibility under tight deadlines.
Analyzing data for efficacy.
Contributing to the management of the catheter development with cross-functional teams following design control processes while generating medical product requirements/specifications, FMEA/Hazard analyses, design reviews, validation testing, in-vivo/in-vitro animal testing, DHFs, etc.
Ensuring a smooth transition of new products into manufacturing.
Assisting in training/overseeing technicians and assemblers.
Contributing to the development of the company’s intellectual property portfolio.
Contributing to the development of the medical device's safety and efficacy assessment via FEA, bench and animal testing.
Understanding the company’s quality policy and quality system requirements applicable to tasks.

To be successful, you will bring:

BS in mechanical, materials or equivalent engineering discipline is required. MS degree preferred.
7+ of relevant medical product design and development experience in medical device industry required.
3+ years of experience designing and developing catheters required. Experience in developing catheters for peripheral / coronary applications and energy delivery is highly preferred
Understanding of both Research and Process Engineering activities
A demonstrated track record of generating innovative medical device concepts that can be turned into manufacturable products.
Previous experience ensuring a good design has a smooth transition to manufacturing that translates to scalability and high yields
Demonstrated successful experience in leading internal and external development resources (e.g., consultants, consulting firms, subcontractors) to achieve product development goals.

Other resources and expected knowledge:

Proficient knowledge and skill in Microsoft Office Suite applications.
Comprehensive knowledge of SolidWorks CAD including drafting standards and GD&T.
Well-versed in statistical analysis for demonstrating successful design characteristics through verification and validation activities
Ability to quickly learn and apply new software (e.g. MATLAB, Solidworks, Minitab, etc.) and equipment (e.g. DAQs, load cells, high-frequency pressure sensors, leak detectors, etc.).
Fundamental understanding of mechanical engineering theory including mechanisms, strength of materials, materials, adhesives, and high-volume manufacturing techniques.
Excellent oral, written communication and critical thinking skills.
Organized and proactive in following up on assigned tasks and setting expectations in a timely manner.
Exhibit a great attitude and flexibility as a team player who excels in a demanding start-up environment.
A self-starter with problem-solving ability, and an understanding of objectives and processes across multi-disciplinary functions involved in medical device development.
Ability to present plans and results to multifunctional teams, accept constructive criticism, quickly learn from mistakes and move on.

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