Director, Medical Device Development and Manufacturing

Job Summary

• Experienced manager guiding a team of technical engineers. Considered to be a device subject matter expert (SME), will provide project and engineering leadership in device and/or system identification, feasibility, development, qualification and launch readiness for combination products.
• Area of focus will be leading a team, and where needed, providing guidance regarding identification of user needs, product requirements and specification development, feasibility test development, design verification and validation testing, risk assessments, DHF creation, general project team technical support, and extensive collaboration with both internal stakeholders and external development partners.
• Ensure compliance of establish Quality Management System (QMS) and in compliance with corporate requirements and all applicable FDA Part 4, Part 210/211, Part 820, ISO 13485 and Canadian Medical Devices Regulations (CMDR SOR/98-282), and if required, EU Medical Device Regulation 2017/745. 

Area of Responsibility

• Provide functional leadership for technical device team and consultants
• Provide project and technical leadership to cross-functional teams for projects through clinical development, product registration and launch-readiness
• Ensure team meets current standards on Design Control and DHF expectations, in accordance with regulations.
• Oversee the project execution in compliance with design control SOP. Oversee all technical aspects of the development process including pertinent DHF deliverables, statistically sound design verification protocols/reports, design validation activities, and support with Human Factors studies
• Establish and foster strong collaborative relationships with external design/development, manufacturing partners and service providers
• Support the optimization of design control elements to comply with medical device regulations. Lead or assist in deviation, complaint and failure investigations
• Author/revise standard operating procedures (SOPs) related to medical device and associated systems  aligning with regulatory guideline and corporate policy as required
• Other duties as assigned

Work Conditions:

• Office
• Device Development Laboratory
• Manufacturing Floor
• Warehouse
• Third Party site (as required)

Physical Requirements:

• Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, stoop, kneel, crouch or crawl, climb or balance
• Talk or hear
• Close and clear vision
• Computer/office machines
• Lift up to 25 lbs.
• Some travel outside of company facility as required
• Must wear personal safety equipment (gloves, lab coat, gowning, safety glasses) as required.  

Travel Estimate

• Up to 5%

Education and Job Qualification

• Knowledge of Photodynamic therapy and the device requirements for this type of product
• Bachelor of Science Degree in Engineering required, Master of Science Degree preferred
• Minimum of 8 years cross-functional leadership of teams and projects
• Proven track record of developing and gaining regulatory approval of drug delivery systems a plus
• Knowledge of global industry standards (ex: ISO, AAMI, ANSI, etc.)
• Strong hands on technical leadership skills with a track record of delivering products to market
• Strong communication skills (written and verbal), including experience presenting in front of multidisciplinary audiences is expected
• Prior experience leading projects that include managing external design, development, and manufacturing partners
• Ability to mentor technical and cross-functional team members
• Effective planning and organizational skills
• Excellent writing and oral communication skills
• Ability to collaborate with Quality, Manufacturing, Regulatory, R&D, Clinical, Legal
• Ability to both lead as well as support as a technical individual contributor

Experience

• 15+ years of experience in the field of medical device or combination product development and commercialization is required
• Experience in developing and commercializing regulated devices/ combination products under Design Control (21 CFR 820), ISO13485, and ISO14791 requirements
• Extensive knowledge of engineering principles, concepts and applications.
• Strong knowledge of project management techniques, tools and metrics. An aptitude for project foresight and contingency planning
• Experience interacting with external partners, including testing laboratories, CROs and CMOs
• Strong collaboration skills with external partners, including external design, development, and manufacturing partners

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).