Assoc Director, Device Engineering

Job Description

We are seeking a people-focused and technically strong Associate Director of Device Development to lead a team of engineers in the design and development of parenteral drug-device combination products, including autoinjectors, prefilled syringes, and needle safety systems. This role is a first-line people manager position, responsible for developing talent, fostering a collaborative and high-performing team culture, and ensuring successful execution of device development programs. The ideal candidate will bring a balance of technical leadership, strategic thinking, and people management to drive innovation and execution across the portfolio.

Key Responsibilities:

• Lead, manage, and develop a team of engineers, providing coaching, performance feedback, and career development support.
• Foster a culture of collaboration, accountability, and continuous improvement within the device development function.
• Oversee technical execution of combination product development programs, ensuring alignment with design control and regulatory requirements.
• Ensure high-quality documentation, including design inputs/outputs, verification, validation, and risk management deliverables.
• Contribute to regulatory submissions, including INDs, NDAs, and other global filings.
• Collaborate cross-functionally with Regulatory, Quality, Clinical, and Manufacturing teams to align on strategy, timelines, and risk mitigation.
• Support technology transfer to clinical and commercial manufacturing sites.
• Drive problem-solving and root cause analysis for product quality investigations and change control activities.
• Represent the team and function in internal and external meetings, including with suppliers and partners.

Basic Qualifications:

• Doctorate and 5+ years of relevant experience OR
• Master’s and 8+ years of relevant experience OR
• Bachelor’s and 10+ years of relevant experience

Preferred Qualifications:

• Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or related field.
• Minimum of 10+ years (BS) or 8+ years (MS) of relevant industry experience in combination product development.
• Prior experience managing or mentoring engineers in a technical environment is required.
• Strong understanding of design control, risk management, and regulatory standards (FDA, EMA, ISO 13485, ISO 14971, cGMP).
• Proven ability to lead teams, manage performance, and build a positive team culture.
• Excellent communication and interpersonal skills; able to influence across functions and levels.
• Demonstrated ability to solve complex problems and make decisions aligned with organizational goals.