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Director of Engineering

3 months ago

Newark, United States PuraCath Medical Full time

Job description


We are an early-stage med tech company based in Newark and seeking an experienced, dynamic and collaborative Director of Engineering to join its team. This candidate will lead the company's R&D activities to launch new product development and existing product improvement initiatives. The Director of Engineering will be responsible for the development of specifications and leading design activities. This is a managerial as well as technical engineering role that requires investigation of new processes and application of advanced engineering methodologies. The Director of Engineering will work in a cross-functional team environment and will oversee and mentor junior engineers.


Responsibilities of Director of Engineering Candidate:


• Lead the R&D team to develop new products and existing product improvement initiatives for multiple clinical applications in parallel

• Be able to effectively and efficiently manage contract manufacturing partners and vendors.

• Identify and analyze design problems to achieve optimal solutions that satisfy technical requirements

• Formulates new, innovative approaches (IP) to solve technical problems

• Leads product specifications, risk documents and conducts technical and design reviews

• Ensures that project deliverables meet Company, FDA and ISO requirements

• Supports, prepares, and participates during internal and external audits

• Deal with FDA directly, be able to work easily with regulatory consultants and professionals, as well as be very familiar with quality procedures and compliance with ISO13485 standards and 510K applications

• Build and implement capability in project planning, resource management, and integrated project reporting; able to hit milestones effectively

• Develop and deliver clinical training programs using effective communication and presentation skills; clinical trials management and training of nurses and physicians on devices from the Company

• Lead decision analysis with the team in R&D

• Identify and negotiate functional resources to assemble an appropriate cross-functional project team within budget

• Provide technical knowledge and project management expertise to project programs (in various functional areas as necessary) to ensure proper focus and advancement.

• Communicate effectively with management, quality and regulatory professionals, and others regarding the status of all activities and align them to project deliverables.

• Inform management in a timely manner of any problems, which may result in a delay in project schedules. Identify means to minimize impact to the project timeline and budget.


Requirements:


• BS in Mechanical or Biomedical Engineering, Masters and/or PhD preferred; Electrical Engineering/CS and/or Optics knowledge and experience preferred

• 6-12+ years of product development experience in the medical device industry

• Experience in optics and optical engineering, microbiological test protocols and microbiology, electrical engineering, and plastic injection molding is a plus; being able to communicate with the right technical specialists listed above is a must.

• Demonstrated ability to solve complex design and engineering problems

• Experience building experimental test set-ups to characterize and assess functional performance of medical products

• Experience in patent writing and in formulating and interacting with patent counsel, design of technical protocol testing and in leading design, development, verification and validation processes in medical device development process is a must

• Excellent communication skills needed


Key relationships include and not limited to: Quality, Regulatory, Engineering, Marketing, Manufacturing, Procurement, Clinical Specialists, Hospitals, and External Vendors.