Manufacturing Engineer II, Capital Equipment

Manufacturing Engineer II, Capital

This position is based in our Campbell, California offices. This position is on-site & full-time.

At Imperative Care, we are developing novel robotic-assisted technologies and interventional capabilities that will forever change the disparate outcomes of ischemic stroke - a disease that impacts close to a million people a year in the U.S., and 10 million worldwide. Not only is Imperative Care changing the way stroke is treated, but also bringing this treatment to the greater population who is currently without.

We are actively building a team who is focused on developing novel solutions for this complex disease - a disease in which one in four adults will face in their lifetime.

An individual in this role uses strong hands-on experience to execute and deliver assigned projects/products to ensure manufacturability, supporting technology transfer from design to manufacturing and ultimately scalability for commercialization for complex electromechanical capital equipment. This position will complete projects related to in-house manufacturing, manufacturing engineering, and equipment planning/engineering in accordance the company’s Quality System and customer requirements.

• Assist in the construction of prototypes for new products/processes or current product enhancements.
• Provide support to in-house manufacturing activities to verify products are manufactured in accordance with product plans and quality/regulatory requirements.
• Work with Supply Chain to verify inventory of raw materials and components are available per the planned build schedule, monitor and be accountable for material issued to production/projects.
• Develop manufacturing processes and Manufacturing Process Instructions (MPI’s) and lot history records (LHR’s) or Device History record (DHR’s) in collaboration with R&D and Quality
• Conduct time studies for each manufacturing process and identify process development initiatives
• Work with Quality personnel to define in-process inspections and testing and resolve quality and yield issues through continuous improvement projects
• Inform and coordinate with multi-functional operations project team activities from early project conceptualization through clinical testing
• Complete, maintain, and monitor manufacturing tasks of project schedule, and ensure that critical timelines and/or budgets are established and met
• Participate in manufacturing team meetings to ensure communication between members
• Build positive proactive working relationships with team members and other staff members
• Complete manufacturing specifications for products; coordinate all process validation activities with Quality- IQ/OQ/PQ.
• Determine tooling and equipment needs for the timely and cost-effective manufacture of products
• Work with R&D staff to facilitate smooth transition of products into manufacturing while assuring manufacturability, achieving cost targets and conformance with regulatory and Company requirements.
• Collaborate with suppliers to ensure parts/services are properly documented and meet specifications
• Review specifications for sub and final assemblies
• Support manufacturing line and approve DCO’s for manufacturing engineering
• Support the training/certification of the MPI Trainer for manufacturing process instructions; may train other staff as needed
• Using continuous improvement techniques, work with Quality Assurance to identify and implement programs to drive down cost and improve yield and reliability

• Bachelor’s degree in Engineering or related discipline and min 2 years of related experience; or equivalent combination of education and work experience.
• Knowledge of and exposure to product testing and data collection
• Excellent communications skills (both written and verbal) required
• Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD
• Experience in pilot/production line set-up, validation in a controlled environment is preferred.
• Familiar with GMP, GDP procedures and requirements
• Ability to work independently or in team setting required
• Project management experience preferred