Saint Louis, MO
Posted 313 days ago
The Executive Director will lead the R&D hardware engineering and design team and oversee the technical development of ophthalmic surgical equipment products. This is a leadership position in the R&D surgical equipment organization with a focus on electrical & electronics design, mechanical design, systems engineering, and compliance engineering.
This person will have expertise and experience in all hardware related design areas, as well as experience in direct functional management of engineering teams. They will lead the hardware engineering and design functional group. They will lead individual product design or root cause investigation teams from time to time on an as-needed basis.
Primary activities will include active cross functional coordination of product design activities with commercial, operations and regulatory leadership including interface with key customers, functional leadership and planning within the development group, performance review within the development group, identifying and filling future resource gaps, new product proposals, new project planning including identification of initial budgets, schedules, resources and risks, and technical guidance in mechanical, electrical and systems design and regulatory compliance engineering.
Lead the R&D hardware engineering and design team and oversee the technical development of ophthalmic surgical equipment products.
Provide guidance and assistance in the modeling and technical specification of new product needs and opportunities.
Assign internal engineering resources, and identify external resources, in support of product hardware design, systems engineering, and compliance engineering efforts.
Collaborate with the R&D Program Management team to identify areas for future product development and assist in proving concept feasibility.
Collaborate with the surgical equipment commercial team to expand and enhance the product portfolio.
Work with the Patent Law group to file, execute, and maintain surgical equipment U.S. and foreign patents.
Assist the project teams in ensuring risk management and compliance engineering requirements (e.g., B&L, FDA, LGA, and IEC design control policies, procedures, and standards) are identified and properly addressed.
Participate in cross-functional program, project, and risk management reviews
The design director is responsible for the functional management of mechanical, electrical and systems engineering engineers engaged in the design of ophthalmic surgical equipment, single use disposables, and related accessories.
Key relationships with
• External customers for voice of customer development for new product concepts and product feasibility evaluations
• External business partners at suppliers in order to establish component availability and cost for feasibility and root cause resolution projects
• Internal business partners including leaders and managers in R&D, commercial sales and marketing, regional quality, site quality, manufacturing engineering, procurement and supplier quality.
Bachelor of Science degree in Electrical, Mechanical, or Systems Engineering
Equivalent experience may be considered
Master of Science degree or PhD in Electrical, Mechanical or Systems Engineering
Knowledge of domestic and international medical device regulatory requirements, engineering methods, principals of electronics, mechanics, and statistics, good business practices and effective written and oral communication.
At least 20years of experience in product design across multiple disciplines.
At least 20years of experience in ophthalmic medical device design.