Sr. Manager/Associate Director, Manufacturing and Engineering

POSITION OVERVIEW

The Sr. Manager/Associate Director, Manufacturing & Engineering is a hands-on role, responsible for providing division wide engineering support and bridging the gap between new product development and commercial production at Adagio Medical. This position leads a multi-disciplinary team in developing, validating, and optimizing manufacturing processes. This role is responsible for ensuring a smooth transition to commercial scale, prioritizing design for manufacturability and ensuring processes remain compliant with applicable regulatory standards. This position will be responsible for contract manufacturing oversight including site and collaboration travel.

ESSENTIAL DUTIES

• Drives design for manufacturability and design for assembly initiatives to reduce complexity and cost.
• Hands-on management of cleanroom facilities and supervision of technician teams to ensure operational efficiency.
• Leads development of pilot production lines, ensuring equipment, layouts, and workflows remain optimized.
• Manages creation and maintenance of manufacturing execution systems, work instructions, and DMR’s.
• Oversight of agile system lifecycles, ensuring scalability and efficient operations within manufacturing environment. Develops and tracks key performance indicators where applicable.
• Ownership of validation lifecycle, including IQ/OQ/PQ.
• Ensures all manufacturing processes and documentation comply with applicable ISO’s and regulatory requirements. Ensures all safety policies and procedures, required GMP’s, and manufacturing procedures are followed correctly.
• Services, troubleshoots, and problem-solves for processes or equipment already in operation. Provides engineering support, including recommendations and tactical implementation.
• Strong understanding of current IT and OT platforms, as well as corresponding validations and controls.
• Collaborates with Regulatory Affairs and Quality Assurance to resolve any non-conformances and CAPA’s related to production.
• Actively fosters a culture of engagement, technical excellence, and continuous improvement amongst staff.
• Collaborates with domestic and international CDMO partners to support technology transfer, process scale-up, supplier qualification, and sustained manufacturing operations.
• Performs other duties as required or as assigned by supervisor.

QUALIFICATIONS

• B.S. in Engineering (ie. Mechanical, Biomedical, or Manufacturing). Master’s degree a plus.
• 10 years in medical device manufacturing engineering, with at least 5 years in leadership capacity.
• Experience managing cleanroom facilities and supervising technicians.
• Strong hands-on problem-solving and technical acumen with track record of resolving operational and equipment issues.
• Excellent written and verbal communication skills with strong cross-functional collaboration.
• Demonstrated track record of successful FDA/Notified Body audits with comprehensive understanding of risk management.
• Experience working with global CDMO/CMO partners, including supplier development, technology transfer, and production scale-up activities across Asia and Latin America preferred.
• Experience leading cross-cultural teams and managing international manufacturing relationships in regulated environments preferred.
• Experience in start-up environments a plus.

PHYSICAL REQUIREMENTS

The role requires frequent engagement within a manufacturing environment, characterized by varying noise levels. Success requires an ability to maintain focus and lead teams effectively within these environments. Prolonged periods of sitting stationary with the use of a computer and/or other office equipment required. Occasional standing with the ability to traverse tight spaces and maneuver up to 25lbs required.

This employer participates in E-Verify, a federal program to confirm the employment eligibility of new hires. If you have any questions about the E-Verify process or your rights, please visit the E-Verify website or contact Human Resources.

Consistent with the Americans with Disabilities Act (ADA), CDPA, and FEHA, it is the policy of Adagio Medical to provide reasonable accommodation when requested by a qualified applicant or candidate with a disability, unless such accommodation would cause an undue hardship for the company. The policy regarding requests for reasonable accommodation applies to all aspects of the hiring process. If reasonable accommodation is required, please contact HR@adagiomedical.com.

Adagio Medical is committed to creating an inclusive and equitable workplace where all individuals are valued and receive equal opportunities for employment and advancement, regardless of their race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected status or characteristic.