Director of Engineering

Director of Engineering/Product Development - Medical Devices

Our client, a privately held neuro-diagnostic medical device developer and manufacturer with headquarters and distribution in South Carolina, is ready to grow to their next level of performance and revenues.  They are seeking an Executive - Director of Engineering/Product Development to provide leadership and management oversight to their engineering staff, product development group and quality processes.  As a member of the Senior Management team, this position will have strategic corporate performance responsibilities as well as tactical product development, engineering, regulatory compliance and manufacturing oversight.

This is a unique opportunity for the right person to bring their high-performance expertise, preferably from within the Medical Device industry, to this fast-growth firm.   They are offering a competitive compensation package and an opportunity to help take the company to the next level.

Specifically, we are looking for a senior engineering manager with 10 plus years of engineering experience in medical devices, 5 or more in engineering management, and preferably  with some practice dealing with biomedical materials usage and device development. This experience would have included dealing with FDA and CE Medical Device directives and Regulations.  Experience with Canadian and Asian medical device directives is a plus.

Further, the ideal candidate will have strong tactical skills, experience in managing quality processes and creating accountability in their staff of engineers, product designers and regulatory managers.   They will have been able to effectively translate customer and market wants and needs into design and development characteristics with an eye on manufacturing quality and distribution efficiencies.

Reporting to the Chief Operating Officer, the right individual will join a company that rewards and recognizes individuals who have demonstrated high integrity, are self-directed but also enjoy working as part of a high-performing team.

Requirements

• A Bachelor’s Degree in Engineering or Applied Science. Masters Degree desirable
• Minimum of 5+ years experience in engineering management and a total of 10+ years engineering in a medical device field or other highly regulated life sciences industry
• Experience with FDA and CE Medical Device Directives and other directives as applicable
• Operations mind-set, understanding the fundamentals of a customer and market focused manufacturing operation and a balance of basic business principles
• Effective communicator, written and oral, throughout the organization as well as with customers and suppliers
• Strong tactical skills with experience managing processes through the work of others Able to build commitment and a bias for action from those managed
• Working knowledge of ProE software, project and program management tools and software as well as efficient use of Microsoft office products. PMI certification is a plus as well as six-sigma and lean manufacturing