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Job #02843

About our client Our client is a globally recognized medical device company headquartered in Ohio for over 100 years. They specialize in manufacturing devices for patients that are easy to use and affordable. They have many products on sale on the market today! They boast a 58 square-foot state-of-the-art manufacturing facility, an experienced management team and an excellent development program. This is a great opportunity for the successful candidate! Position Location Director of Development and Engineering Cleveland, Ohio Salary Highly competitive package, commensurate with experience Responsibilities 1) Lead, manage and build product and process development as well as engineering efforts of clients 2) Utilize mechanical, chemical, electrical and pneumatic engineering and associated technologies to improve ability to meet current and targeted customer needs 3) Oversee the development of comprehensive, well-ordered and logical project plans to deliver new and modified products and processes in a timely manner 4) Develop and deploy design and engineering change processes consistent with activity and documentation standards provided by cGMP and ISO guidelines 5) Ensure production feasibility of product design specifications on a basis that meets project timelines and eventual customer demand 6) Provide support (as needed) in an effort to continually improve cost, quality and product delivery 7) Ensure that process or equipment changes are verified and validated as compatible with existing and planned products 8) Ensure that appropriate installation, operation and production qualification documents are consistently prepared and executed 9) Develop RD&E procedures, processes and criteria that promote the achievement of market, technical, regulatory and manufacturing goals 10) Determine design and manufacturing feasibility of applying company’s products and processes to new market segments along with planning and executing them accordingly 11) Understand and provide vision, strategic guidance and customer needs to help diversify market segments 12) Guide the Senior Management Team (CEO, President, VP of Sales, etc.) in assessing new technology and development pathways that are consistent with market opportunities and likely competitive dynamics 13) Expand technology and product offerings to meet opportunities 14) Comply with all company policies, practices and procedures 15) Lead and manage the Development and Engineering Department 16) Participate in internal and external audits 17) Assess and develop the company’s intellectual property to protect and extend market access and success, working with intellectual property counsel and other advisors (as appropriate) 18) Ascertain and ensure ability of outside suppliers to meet company requirements for materials’ production, component manufacturing and full outsourcing of product processing and assembly 19) Work with Regulatory Affairs and QA Department to refine and adhere to current cGMP, ISO as well as other FDA processes and standards 20) Support and initiate (when appropriate) clinical research work and activities surrounding the technical aspects of customer service 21) Work collaboratively with the Sales and Marketing, Regulatory Affairs and Quality Assurance, Production as well as Finance Departments to achieve goals Requirements 1) Master of Science/Engineering or other advanced technical fields (Applied Physics or Biomedical, Mechanical, Chemical or Electrical Engineering) or MBA/Technical Management preferred 2) 10 – 15 years of experience in engineering, R&D and product development 3) Experience in handling ‘at introduction’ cost, quality and delivery characteristics of new products 4) Experience in a prescription medical device, OTC consumer health, or pharmaceutical products company, utilizing reagent/medicine delivery, aerosol delivery, unit packaging and pneumatic or electronic control technologies 5) Experience in key engineering systems (CAD/CAM/CAE) and capital planning 6) Experience in coordinating, liaising and interfacing between sales, marketing, manufacturing as well as technical functions 7) Knowledge of and experience in FDA and the 3 classes of medical devices 8) Good project management and commercialization skills 9) Proficiency in MS Office suite of desktop computing applications and other computer skills 10) Excellent interpersonal and communication (written and oral) skills