Vayu Global Health · 2 days ago
Lead Manufacturing Engineer
Medford, MA
Full-time
Onsite
Senior Level
$80K/yr - $90K/yr
5+ years expVayu Global Health is a company dedicated to advancing newborn and child health through high-impact work. The Lead Manufacturing Engineer oversees production at multiple international contract manufacturers, ensuring quality and efficiency while collaborating with various teams to address quality issues and optimize manufacturing processes.
Non-profit Organization Management
Responsibilities
Primary oversight of two contract manufacturers (one in Kenya, one in India, with potential for additional assembly sites)
Regular monitoring of contract manufacturers to ensure compliance and prevent quality issues. Includes review of batch manufacturing records, site inspections (requires travel), performance metric review, etc
Collaborate with multi-functional, international teams to address root causes of quality issues and implement sustainable solutions through investigations, CAPAs, etc
Lead initiatives to optimize existing manufacturing processes, focusing on efficiency and quality improvements
Participate in ISO 13485 audits and lead sections showing oversight over contract manufacturers
Assist with regulatory research, preparation of submission materials, and coordination of documentation for global market registrations as needed
Support design change activities by ensuring manufacturing impacts are assessed, documentation is updated, and changes are properly implemented in accordance with design control and change management procedures
Assist with UDI assignment, labeling coordination with contract manufacturer, and maintenance of device traceability records in alignment with applicable regulatory requirements and internal procedures
Assist with DfM and design transfer of new products to contract manufacturers
Qualification
Required
Bachelor's degree in Engineering (i.e. Mechanical, Biomedical, Electrical)
5+ years relevant experience in the medical device industry
Experience collaborating with contract manufacturer(s)
Knowledge of ISO 13485, especially production controls and supplier oversight
Able to process data, interpret it, and make recommendations based on findings
Demonstrated ability to take initiative, work in a small team, and drive forward projects in line with the organizational priorities
Able to handle a variety of projects, be flexible, troubleshoot, and manage priorities
Strong communication with technical and non-technical teammates. Able to be detail oriented and zoom out to discuss the big picture
Preferred
Demonstrated experience contributing to technical dossiers for regulatory submissions (esp. CE Mark)
Proficiency in statistical methods
Experience with quality management system audits
Benefits
Benefits
Company
Vayu Global Health
Vayu collaborates with thought leaders and faculty from Harvard, MIT and the Massachusetts General Hospital to incubate quality cost-efficient healthcare solutions that can be delivered at scale.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase