Director, Device Engineering

Job Description

As a Director, Device Engineering you will lead the medical device engineering team in the research, development and implementation of medical device products throughout conceptualization, development, clinical to commercial use.

OBJECTIVES:

• Combines knowledge of scientific, regulatory, quality, and business experience to ensure timely delivery of medical device products, to be used for the delivery of MeiraGTx’ s gene therapies.
• Utilize knowledge and expertise of device and CMC regulations, establishes cross function and leadership communications to relevant stakeholders, thereby driving prospective and proactive implementation.
• Globally influences and is considered a key opinion leader and resource within MeiraGTx and externally with stakeholders, regulatory and health authorities.
• Acts as an advisor/liaison to senior management to plan, evaluate and recommend implementation device engineering strategy.
• Establish collaboration with Global CMC teams and leadership through networks and enable Device Engineering Team’s success in meeting goals/objectives.

RESPONSIBILTIES:

• Responsible for demonstrating MeiraGTx leadership qualities.
• Provide leadership of Device Engineering team and in conjunction with direct reports and external consultants,  manages resources, establish a vision, and collaborate with stakeholders across the enterprise to deliver against them.
• In conjunction with members of the team, develop as well as oversee development (including updates) and communication of proactive medical device strategies to global teams and stakeholders in a timely manner
• Builds and manages relationships through active partnering with key internal (Preclinical, Clinical Operations, Regulatory, Quality, Drug Manufacturing Sciences and Technology etc.) and external stakeholders (Health authorities, Industry counterparts/associations, academia).
• Ensure team effectiveness in working across a very complex matrix to ensure effective strategies are developed and project execution is on target.
• Actively engage and influence organization to think proactively and utilize science and risk based approach to medical device development.
• Contribute to creating and communicating an employment culture and values which attract, retain, and develop the most effective people.
• Ensure compliance with all applicable MeiraGTx SOPs, and industry best-practice.
• Provide support, as required, to the regulatory function in the evaluation of new product opportunities internally and externally.
• Manage external suppliers, contractors, and vendors with support from internal team.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Advanced Degree or PhD in Life Sciences, Engineering, or related discipline.
• Languages: Fluent in English (oral and written); additional languages desirable
• Significant understanding and track record in developing medical devices from concept to commercial stage.
• Strong communication, collaboration, negotiation, problem solving and interpersonal skills. Has a proven track record of working across regulator/industry boundaries to find common solutions and drive positive impact and benefits for patients.
• High organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in teams.

TRAVEL REQUIREMENTS:

• Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.