We are currently searching for a creative, dynamic, and experienced engineer to manage vendors relationships, manufacturing, procurement transition our products from development to production, reporting to the COO of the company.
Essential Duties and Responsibilities in this position
· Interface with vendors/partners and advise R&D/engineering team on all aspects related to production and design-for-production
· Participate and sometimes lead selection of materials and components
· Plan and coordinate V&V-related testing such as environmental testing, production validation and other relevant testing
· Select and manage production suppliers and sub-contractors
· Plan and implement the production method and production lines
· Co-work with QA/QMS team to define, apply and maintain compliance of the production process with relevant regulatory requirements, and with Quality Management System %28QMS%29 procedures.
· Liaise with other managers to formulate objectives and understand requirements
· Estimate costs and prepare budgets
· Organize workflow to meet specifications and deadlines
· Monitor production to resolve issues
· Supervise and evaluate performance of production personnel %28quality inspectors, workers etc.%29
· Track products costs and perform evaluation to achieve cost optimization
· Log and maintain every part numbers, BOM’s, manufacturing routers along with work orders in different software supporting manufacturing production
· Provide cost evaluation, manufacturing documents and develop Bill-of-Material for new projects and products
· Assist in conducting product and process analysis for quality improvement, cost reduction and enhanced efficiency.
Qualifications
Education
· B.Sc. in electrical/mechanical/industrial engineering
Skills & Abilities
· Assertive, creative, resourceful, result-oriented, responsible, reliable
· Excellent inter-personal communications and high-level presentation skills
· Excellent English – written and spoken
· Good team-work mentality
· Willingness to travel abroad
· Proven experience as manufacturing/production director
· Deep knowledge of production management
· Understanding of quality standards and health & safety regulations
· Knowledge of performance evaluation and budgeting concepts
· Experience in reporting on key production metrics
· Proficient in MS Office and ERP software
· Attention to detail
Experience
· At least one complete %28A to Z%29 cycle of bringing from development to mass production an FDA-approved medical device which includes electronic components and software
· Proven experience in managing suppliers, both locally and overseas
· Proven experience in managing product trees, production files, revision history, DMR and DHR, etc.
· Good understanding of mechanical design, experience in managing plastic parts manufacturing, experience with glues and soft materials.