Careers

DIRECTOR, CATHETER AND MECHANICAL ENGINEERING at NinePoint Medical
Bedford, MA, US

Director, Catheter and Mechanical Engineering


 


The Company:


 


NinePoint Medical is a fast-paced medical device start-up based out of Bedford MA. With our recent


strategic investment from Merit Medical, we are expanding our product development team. We


develop, manufacture and commercialize cutting-edge medical imaging products with a big vision to


detect, diagnose, and treat cancer before it becomes cancer. Today’s standard of care for diagnosis of


disease relies on obtaining a tissue sample and performing costly processing and expert review of


tissue sections. Using breakthrough optical imaging technology along with advanced machine


learning algorithms, NinePoint Medical will provide treating physicians with real-time diagnostic


capability, thus streamlining patient care, reducing cost, and improving outcomes. The research and


development team is composed of a small but diverse group of talented electrical, mechanical, optical,


imaging and software engineers who strive to make a direct impact on patients’ lives every day.


 


Position Requirements:


 


This is an exciting opportunity to join NinePoint and work on the development and commercialization of


state-of-the-art medical imaging devices. We are seeking a motivated and hands on individual to direct,


oversee and manage our catheter device and mechanical engineering teams. This position will be


responsible for leading the design through commercialization of single-use catheter devices incorporating


NinePoint Medical’s advanced imaging technology. In addition, this position will also own and oversee


the mechanical engineering activities, with specific focus on our next generation imaging instrumentation.


The qualified candidate will need to lead a cross-functional team through concept, design and


development and will report directly to the Vice President of Research and Development. This is a critical


and challenging position with many moving parts requiring strong technical and managerial skills.


 


Key Responsibilities:


 


Inspire, rally and lead the Catheter Device and Mechanical Engineering team


Participate in brainstorming, prototyping and analysis of next generation catheter device and


electro-opto-mechanical concepts and designs, help form future roadmap


Work alongside talented electrical, mechanical, optical and imaging engineers to develop


innovative solutions to real world medical problems, push the status quo


Engineer solutions using proven and innovative manufacturing techniques


Participate in risk management activities across product portfolio


Decompose projects into discrete tasks and work with management to effectively resource,


schedule and provide status updates


Formulate and support the required preclinical testing to prove safety and efficacy


Mentor and supervise engineers


 


 


Required Experience:


 


 


10+ years of relevant experience in the design and commercialization of catheter/disposable


devices


5+ years’ experience with direct reports


Project management, risk assessment and resource planning


Experience determining the clinical user needs and gaining feedback directly from the


practicing physicians


Experience working in a regulated industry, specifically under FDA QSR, UL/IEC 60601 and


ISO 13485 design control requirements


 


 


Desirable Experience:


 


 


Endoscopic or vascular catheter experience


Strong understanding of plastics used in medical applications


Plastic processing: balloon forming, injection molding, extrusion


Catheter bonding operations (thermal, adhesive)


Solid understanding of statistics for both design and process applications


Process automation as related to catheter manufacturing


Mechanical engineering of medical instrumentation


Robotics and motion control systems


 


 


Education/General Requirements:


 


 


A minimum of a technical Bachelors or equivalent required. Masters Degree desirable.


Preferred fields: Biomedical engineering, Plastics engineering, Mechanical engineering,


Chemical engineering


Strong customer focus, highly organized, responsible and detail oriented


Excellent written and verbal communication skills - must be able to write clear reports,


specifications, proposals and effectively discuss them with other members of a multidisciplinary


team (R&D, MFG, Quality, Clinical, Marketing, Sales)


Clear understanding of the role of engineering in a manufacturing environment and proven


track record of transferring designs into manufacturing


Exposure to reliability engineering


 


 


The Nine Points for Success


 


1. Excellence: constantly create high quality products that improve patient care


2. Quality: be better than industry standard in the quality of our people and the efficiency of


our operations


3. Accountability: Cultivate individual responsibility and promote personal and professional


growth


4. Innovation: value high quality innovation


5. Commitment: create and maintain a positive work environment that is fun and rewarding


to be a part of


6. Teamwork: value relationships that build respect and foster team work


7. Communication: utilize good communication


8. Empowerment: make a difference


9. Diversity: value diversity of people and opinion