FullTime
Allen, TX
Posted 2 weeks ago

Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 7+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.

 

Position Title:

Vice President of New Product Research – direct hire / full-time

 

Reports to:

President / CEO

 

Department:

R&D

 

Location:

Allen, TX 75002

 

Summary:

The Head of New Product Research (engineering and product development) for Quest Medical will set long-term strategic plans and directions for the investigation, design and execution of new or improved products and/or applications working with Marketing, Clinical and Business Unit functional heads. Responsible for overall NPD portfolio value and viability following a stage gate process. Develops R&D strategy for the group in accordance to business strategy, including capability & technology roadmaps and R&D footprint strategy, focusing on Phases 0 through 3. Ensures excellence in execution of research and early stage development programs, in accordance to customer value proposition and internal performance metrics. Actively interacts with customers and key technical staff to help accelerate their rate of innovation and speed to market for new products.

 

Through customer focus, continuous development of critical capabilities and world-class execution, builds a robust pipeline of early stage development activities. Develops a culture of excellence focused on execution with superior project management of all research projects. Provides input to the group’s acquisition strategy, and will be a member of the diligence team when needed. Mentor technical and senior level executives on technical, product and clinical issues with a strong emphasis on talent development.

 

 

Role:

The Vice President of New Product Research is responsible for creating and leading the medical device pipeline for core Quest business segments in Infusion, Cardiac Surgery and Ophthalmology, and other market opportunities. In furtherance, will develop strategies and assessments of white spaces to derive new product and platform ideas / concepts and champions internal consensus. He/she provides functional expertise in support of key business strategies, ensuring competent and empowered resources are provided to NPD teams. Will also create a culture of empowerment, while developing and mentoring functional resources to support business objectives. This role has leadership responsibility for talent development comprised of roles in medical device engineering, clinical science and product development.

This role will work closely with Head of Product Development (Phase 4-5), senior business development and marketing personnel to provide technical expertise, evaluation and strategy related to external technology opportunities. The role participates as a member of the SRLT (senior leadership team) reports into the President / CEO. She/he will also interact and liaise with external content experts as the strategic face for R&D device development and engineering

 

Requirements:

  • Bachelor’s degree or higher in an engineering discipline or a scientific discipline.
  • 15 years’ experience in engineering and product development with demonstrated capability and understanding of the product development process; knowledge of sound design principles, regulatory requirements and product and process validation procedures; be resourceful and possess above-average skills in product development, project management and personnel management and strategy development.
  • Track record of bringing innovative medical devices from concept through development and validation to the marketplace in both the US and Europe
  • Clinical knowledge of cardiac surgery or other invasive procedures is desired.
  • Good writing, analytical and communication skills and ability to maintain a creative environment and motivate technical personnel. Knowledge of formal training in total quality management is desired.
  • Proven track record building a strong technical community and team leadership globally. Experience leading a large team of Research Engineers.
  • Thorough understanding of FDA Quality System Regulations and ISO 13485
  • Experience with all phases of the product life cycle process (exploratory, technology development, product development, and sustaining). Expertise with early stage development Phases 0-3 highly desired.
  • Experience working with capital equipment related medical devices.
  • Demonstrated experience managing a department budget is required.
  • Demonstrated experience in leading people, ideally of different functions and scientific disciplines.
  • The ideal incumbent would have a tracker record of success in career development, mentoring, and building relationships in cross-functional team environments.

Responsibilities:

  • Develops and drives long-term strategic investments and goals of division.
  • Partners internally with Product Development, New Business Development, Research, Portfolio, and other divisions to foster and drive innovation.
  • Partners externally with Universities, venture capitalists, physicians and industry specialists (key opinion leaders) and hospitals to drive innovation.
  • Proactively manages cost, schedule and performance of portfolio investments (exploratory, technology development, product development, and sustaining).
  • Sets performance expectations for the division.
  • Collaborates on intellectual property security of division.
  • Develops and Drives technology roadmaps for the division globally.
  • Creates and maintains technical centers of excellence, which are comprised of experts who can address divisional and cross-corporate technical issues.
  • Manage financial and engineering resources to develop sterile disposable and electronic products and manufacturing processes according to planned schedules, focused on Phase 0-3.
  • Work with Sales and Marketing to identify and define product opportunities.
  • Develop and adhere to a project-based operating plan and yearly budget.
  • Follow design control activities and for ensuring all product development activities are compliant with FDA design control regulations.
  • Develop Research personnel to be proficient at utilizing computers to improve project planning, design accuracy and design capability in pursuit of Quest’s goal to do things right the first time; on time.
  • Actively manage Research personnel to the attainment of individual professional growth in areas of engineering, manufacturing, management and clinical application by providing the motivation and opportunity to obtain further training.
  • Ensure that customer and applicable regulatory requirements are met.
  • Imbibe a culture of continuous improvement and mission centric mindset

 

Notables / Benefits:

  • Mid-size company with great company culture that is well diverse
  • Have a voice in the company
  • Average tenure for employee population is 7+ years
  • 401k with employee matching available
  • Paid vacation, health/dental/vision, and other excellent benefits

 

 

An Equal Opportunity Employer

Job Features

Job Category

Engineer, R&D

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