Vectorious’ has developed the world’s first in-heart microcomputer and is on a mission to transform heart failure treatment. As part of our first in-human clinical study, we have successfully implanted our sensory device in patients across Europe, while demonstrating a huge potential in helping millions of people living with heart failure to take control and manage their disease, keeping them stable, out of hospitals, and living longer, fuller lives.
We are looking for a Manufacturing Manager to join our Operations group.
Primary Function: 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.
- 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)