Manufacturing Manager

The candidate will establish and oversee the company’s Manufacturing Department.
The candidate will lead the transition from prototype stage production to low-mid volume manufacturing
of a multi-disciplinary medical device which incorporate both mechanical and electronic components and
sub-assemblies.
 
Roles & Responsibilities:
• Plan, maintain and improve “low to mid-volume” manufacturing lines we accordance to the
company’s goals
• Specifying and refining BOMs, work-flow processes, manufacturing plans, detailed work
instructions, inventory and incoming inspection
• Support manufacturing decision-making information by calculating production, labour and
material costs; reviewing production schedules; estimating future requirements
• Analyse manufacturing line risks (PFMEA) to incorporate and validate critical tests during/for
manufacturing
• Take responsibility for maintaining compliance with medical device quality system including CAPA
closure, discrepant material dispositions and ECO implementation, under ISO 13485, CE ad FDA
regulatory guidelines
• Identify and implement continuous improvement projects with respect to first -pass yield, cycle
time reduction, product reliability
• Maintain all documentation associated with the manufacturing line (DMR and DHR records)
• Create, improve and maintain Work Instructions, procedures and processes in relation to
manufacturing plan determine optimal utilization of manufacturing workers and equipment to
meet manufacturing goals .
Qualifications:
• Degree in Mechanical or Industrial Engineering, or related experience – A technical mindset with
great attention to details
• More than 5 years of experience in Medical Device manufacturing environment, with significant
mechanical/ electromechanical content
• Prior experience with complex device manufacturing (an experience with Implantable Devices –
an advantage)
• Previous experience with ERP systems
• Experience in an ISO 13485, ISO 9001 – advantage
• Clean room manufacturing experience – advantage
• IQ/OQ/PQ knowledge – advantage
• Excellent collaboration and communication skills
• Multi-Tasking, Organized and Hands On
• Start Up culture oriented
• Excellent English language skills (verbal and writing)