Head of Manufacturing
1st In Start-Up Manufacturing Lead
Cardiac Arrest : Airway Ventilation Management
Our client, CoLabs Medical, is seeking a very smart, technical, methodical, and organized person with high energy and great attention to detail to join our engineering team. CoLabs is a well-funded SF Bay Area startup medical device company developing the Ventor, an emergency airway and ventilation system which changes how airway management and ventilation are approached during cardiac arrest. A successful candidate possesses the ability to self-start, a strong collaborative mindset, and the ability to thrive in a dynamic environment.
About the Role
Manufacturing Engineers focus on developing failsafe manufacturing processes and building systems to ensure that high-quality products can be delivered on time, and at the right cost, to our customers. This position is a highly technical one and requires the ability to design, specify, implement, and validate semi-automated or mechanized manufacturing equipment. This position will also be responsible for designing the product for manufacturability and serviceability, driving down costs, and working with Quality Engineering. You will be the first Manufacturing Engineer at CoLabs, and therefore will be responsible for making major decisions that impact the company’s success.
● Lead all design for manufacturability efforts
● Develop process verification and validation testing plans, protocols, and reports
● Take part in the risk management process by leading the process FMECA process
● Work with Quality Engineering to select and audit key suppliers
● Apply statistical methods to the testing of products and processes, and implement SPC as necessary
● Own and manage all supply chain efforts
● Own and manage the Device Master Record
● Work with Regulatory Affairs to feed product testing data into regulatory submissions
● Drive down product cost over time as required by the design plan
● BS in Engineering or equivalent
● 8+ years taking products from R&D through to full scale manufacturing, focusing on process validation, manufacturing line layout, fixturing/equipment, failsafing, and supply chain management
● Experience must include both electromechanical durable medical equipment (with software) and high volume medical disposables, spanning at least 3 different companies/product lines
● Needs to be extremely well versed in the theory, principles, and application of statistical methods and statistical process control
● Expert in authoring quality documents (SOPs, WIs, Templates, etc.)
● Experience validating software a plus
Note: This position is required to spend a majority of each week on site in our Morgan Hill offices and may require up to 10% US travel.