Industry: Medical Device

Position Code: 12022

Location: Midlands

This position is responsible for leading a structured development process that proceeds from concept to production and will consider both the business and the technical needs of all customers with the goal of providing quality products that meet and exceed user needs.

The role interacts with members of the Marketing, Quality, Regulatory Affairs, R&D, Manufacturing, and Service functions in the development of innovative, clinically relevant medical products with an emphasis on patient safety and care.  The R&D Director leads Engineers and Technicians on multiple projects.

ESSENTIAL FUNCTIONS:

• Provide technical and managerial leadership over complex, major design and development projects.
• Create and maintain programmatic and technical documentation to ensure efficient planning and execution.
• Produce innovative technical solutions to customer’s clinical needs.
• Identify, prioritize and implement new development capabilities that decrease time to market, development cost, product cost, and increase or maintain development and product quality.
• Support the design review and phase review process to ensure that engineering deliverables are at the appropriate level of completeness and quality, as well as meets applicable medical device standards.
• Drive/lead cross-organization technical collaboration.
• Able to most effectively use inside or outside resources to achieve goals and objectives.
• Responsible for R&D departmental budget.
• Assure staff compliance with all safety and training requirements and certifications.
• Drive change, demonstrate effective decision making, and provide direction for quality operations.
• Active assessment of project and teams’ needs and gaps, and help develop individual development plans for team members.
• Recruit, hire, retain, develop, evaluate, review, and retain high-performance Engineering team.

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:

• Be a proven leader with strong research and development skills and a proven track record of delivering world-class results.
• Leadership experience in the assessment and development of cutting-edge technologies for new products and processes.
• Has demonstrated a progressive career with broad-based multi-disciplinary teams
• Possesses extensive technical experience in running a medical device development organization.
• Embraces being challenged and challenging others around new ideas, processes and new ways of doing business.
• Is a collaborative team player with excellent relationship-building skills.

MINIMUM REQUIREMENTS:

• BS in Mechanical Engineering, Biomedical Engineering, Electrical Engineering or a related field.
• 8-10 years of increased responsibility managing engineering projects
• Minimum five years of medical device industry experience.
• Desired to have Six Sigma black /green belt or experience in DFSS.
• Experience managing large numbers of engineers and delivering successful product releases on schedule.
• Marketing intuition, long term strategic outlook, financially savvy.
• Proven ability to partner with Marketing and Sales organizations to successfully drive the business.
• Solid working knowledge of current quality and regulatory requirements, plus experience dealing with regulatory agencies or outside professional groups (FDA, ISO, ANSI, HIMA).
• Must be a strong communicator across all levels of the organization and with outside customers.
• Must be customer focused and driven: able to understand the customer needs and develop technical requirements from them.

Further Information from:

Micheál Coughlan

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