Director, Device Engineering

We are seeking a dynamic and people-focused Director of Device Development to lead a team of engineers in the design and delivery of parenteral drug-device combination products, including prefilled syringes and autoinjectors. This role is centered on building a strong team culture, fostering cross-functional collaboration, and reinforcing the strategic value of combination products as integrated product systems. The ideal candidate will be a skilled leader who can influence across the organization, drive alignment, and champion the role of device innovation in enhancing patient outcomes. This is a high-impact leadership position with a strong emphasis on team development, organizational influence, and strategic execution.

Specific Job Responsibilities

• Build, lead, and inspire a high-performing team of engineers, fostering a culture of collaboration, accountability, innovation, and continuous development within the device development function.

• Champion a systems-based approach to product development, ensuring that all combination products are treated as integrated systems encompassing drug, device, user interface, and delivery performance.

• Influence and collaborate effectively across the organization, including with clinical, regulatory, quality, commercial, and manufacturing teams, to align on product strategy, development priorities, and risk management.

• Reinforce and communicate the value proposition of drug-device combination products, advocating for user-centric design, differentiated delivery platforms, and the strategic role of devices in enhancing therapeutic outcomes.

• Ensure robust design control and risk management practices are followed across all device programs, in alignment with global regulatory requirements (e.g., FDA, EMA, ISO 13485, ISO 14971).

• Establish and maintain strong relationships with external partners and suppliers, ensuring alignment on technical requirements, timelines, and quality expectations.

Required Education & Experience

Bachelor's Degree and Twelve Years’ Experience

OR

Masters' Degree and Ten Years’ Experience

OR

PhD and Eight Years’ Experience

Preferred Experience

• Experience leading combination product development projects and managing device engineers.

• A Bachelor’s Degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, or a related scientific field and a minimum of ten (10) years of relevant industry OR a Master’s Degree and a minimum of eight (8) years of relevant industry.

• Experience with the development and commercialization of combination products.

• Working knowledge of FDA, EMA, and cGMP standards for combination products.

• Strong verbal, written, and interpersonal communication skills.

• Able to write clear, concise, and error-free documents.

• Able to exercise judgment within well-defined and established procedures and policies in order to determine and take appropriate action.

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams, modelling inclusion, and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals, purpose, organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem