Collins McNicholas

Job Purpose

Responsible for design and development of next-generation minimally invasive medical devices for the treatment of valvular heart disease. Successful candidate will work independently, or as a member of a team within a dynamic New Product Development organisation specialized in transcatheter heart valve system development for commercialization in all major global healthcare markets.

Independently, or as a member of a team, develops, directs, and executes plans for a major segment of complex projects

Under limited supervision/guidance, compiles, analyzes, and reports operational, test, and research data to establish performance standards for newly designed or modified products, processes, and materials.        

Key Responsibilities

Lead engineering design, development and support of next generation and current generation transcatheter heart valve products

Apply Mechanical and Biomedical Engineering knowledge to the design, development and assessment of prosthetic heart valves

Create/develop technical capabilities and expertise related to the design and testing of heart valve technology

Develop hydrodynamic and fatigue test methods and characterisation techniques to evaluate performance of valve prototypes

Perform necessary tasks to successfully translate designs from proof of concept through commercialization including:

Ensure review of existing research, device concepts and data.

Generate valve design concepts, build and evaluate prototypes.

In conjunction with product planning / marketing, collaborate with leading physicians and experts for the purpose of identifying and clarifying customer needs, plans, goals, and progress.

Prepare trade-off studies and implement alternative approaches to mitigate schedule delays and identify areas that require additional investigation.

Solve problems at the component through system level

Conduct tests utilizing existing test protocols, or develop new ones as needed and generate related written reports

Performs data analysis (statistical and practical) and develops appropriate action plans based upon such analysis.

Participate in the specification and direct completion of specific verification/validation testing and analyses required that satisfy both regulatory and internal requirements.

Document concepts, designs and design modifications in accordance with internal policies, industry standards and FDA requirements.

Coordinate with outside consultants and clinicians to ensure testing and analyses required to fully qualify and verify device designs are appropriately representative of expected use conditions.

Work closely with team members and internal partners in Regulatory, Quality, Manufacturing, Marketing and other departments to deliver project objectives

Provide clear and regular technical direction to personnel assigned to a project

Maintain technical knowledge current with advancing technology related to cardiac valve prostheses and associated technologies in addition to knowledge of competitive technologies

Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers related to materials, manufacturing processes and design

Support manufacturing and quality groups for improvements to existing products in the areas of quality enhancement, product cost and product performance.

Prepare or direct the preparation of oral and written reports of current status, progress and status of total project, as required by the customer, project or department Management.

Qualifications

A bachelor’s degree in Mechanical Engineering or Biomedical Engineering is required. An advanced degree is a distinct advantage.

9+ years experience with BS Degree

7+ years experience with MS Degree

4+ years experience with PhD

Position requires relevant mechanical/biomedical engineering experience to include heart valve development, exposure to design of experiments, specification development, and prototyping. Prior experience in an interventional, vascular or cardiac surgery arena a plus, especially involving prosthetic tissues and catheter based technologies.

 

Required Skills:

Experience in the design and development of valve prostheses and associated processes are required

Experience with medical device testing of vascular prostheses and/or catheter delivery systems a plus

Understanding and extensive application of technical principles, theories, and design concepts in implantable products

Good understanding of the Human Anatomy and cardiovascular physiology is strongly desired

In depth understanding of fluid mechanics and computational fluid dynamics (CFD) particle image velocimetry is strongly desired

Broad, working knowledge of manufacturing process for medical devices, design control and Quality Systems.

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