Associate Director - Engineering

Role Summary

Associate Director - Engineering leading the future of manufacturing within the Device and Packaging Network, driving strategy, innovation, and quality objectives on the floor through cross-functional collaboration and strong leadership.

Responsibilities

• Empowerment through Development: Mentor, coach, and recognize team members to foster growth and meet business needs.
• Strategic Planning: Engage with business plan objectives, track performance, and ensure adequate resources for successful implementation.
• Safety and Quality Culture: Lead a safety-first, quality-first culture; review and approve GMP documentation and related regulatory materials.
• Technical Excellence: Provide technical input and process support for manufacturing issue resolution, drive continuous improvement, and adhere to engineering standards across maintenance, process, automation, and capital projects.
• Process Optimization: Develop local processes and procedures to enhance efficiency using lean tools.
• Resource Management: Manage workload and staffing; support site leadership in building a diverse, capable organization for device assembly and packaging.
• Collaborative Leadership: Work with cross-functional teams, external partners, and suppliers to align and resolve escalated issues; represent the team on plant flow teams.
• Performance Metrics: Develop and communicate department metrics; set team goals for safety, quality, and process effectiveness.
• Innovation and Problem-Solving: Foster innovation and drive improvement opportunities; deliver equipment, lines, and systems via technology transfers or process validations as needed.
• Regulatory Compliance: Ensure adherence to cGMP, OSHA, and environmental goals; support inspection readiness; interact with regulatory agencies during site inspections.

Qualifications

• Required: Bachelor‚Äôs Degree in Engineering, Science, or related field.
• Required: 5+ years of manufacturing experience in pharmaceutical or regulated industry.
• Required: 3+ years of demonstrated leadership with a track record of developing teams.

Additional Preferences And Information

• Experience in device assembly and/or packaging.
• Knowledge of cGMP requirements in medical device manufacturing.
• Understanding of regulatory agencies such as the FDA, DEKRA, and OSHA.
• Strong interpersonal, written, and oral communication skills for decisions, influencing, coaching, and mentoring.
• Equipment qualification and process validation experience.
• Experience with deviation and change management systems (e.g., Trackwise).
• Travel: 0-50% depending on site and functional requirements.
• Personal protective equipment required on the manufacturing floor.
• Commitment to maintaining a safe work environment and supporting health, safety, and environmental goals.