Manufacturing Engineer , Capital Equipment

Title:

Manufacturing Engineer I, Capital Equipment

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.
• Assist in development of 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
• 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
• Contribute to manufacturing specifications for products; assist in process validation activities with Quality- IQ/OQ/PQ.
• Support tooling and equipment development and identification 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

• Bachelor’s degree in engineering or related field, and less than 2 years of any other professional experience; or equivalent combination of education and work experience.
• Knowledge of and exposure to product testing and data collection
• Strong communications skills (both written and verbal).
• Experience in pilot/production line set-up, validation in a controlled environment is preferred.
• Knowledge of quality systems design to meet governmental regulations such as FDA QSR, ISO 13485, the MDD, and knowledge of relevant standards is desired.
• Basic knowledge or experience with FDA Design Control procedures and DFSS/DFM tools a plus.
• Familiar with GMP, GDP procedures and requirements.
• Ability to complete tasks independently after receiving detailed instruction and collaborate in a team.

include a stake in our collective success with stock options, bonus, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.

Salary Range: $90, / annually

Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer. As part of our total rewards package, Imperative Care offers comprehensive benefits including a 401k plan, health benefits, generous PTO, a parental leave program and emotional health resources.