Manufacturing Engineer II, Capital Equipment

Title: Manufacturing Engineer II, Capital This position is based in our Campbell, California offices. This position is on-site & full-timeWhy Imperative Care?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.What You’ll DoAn 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 QualityConduct time studies for each manufacturing process and identify process development initiativesWork with Quality personnel to define in-process inspections and testing and resolve quality and yield issues through continuous improvement projectsInform and coordinate with multi-functional operations project team activities from early project conceptualization through clinical testingComplete, maintain, and monitor manufacturing tasks of project schedule, and ensure that critical timelines and/or budgets are established and metParticipate in manufacturing team meetings to ensure communication between membersBuild positive proactive working relationships with team members and other staff membersComplete 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 productsWork 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 specificationsReview specifications for sub and final assembliesSupport manufacturing line and approve DCO’s for manufacturing engineeringSupport the training/certification of the MPI Trainer for manufacturing process instructions; may train other staff as neededUsing continuous improvement techniques, work with Quality Assurance to identify and implement programs to drive down cost and improve yield and reliabilityWhat You’ll BringBachelor’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 collectionExcellent communications skills (both written and verbal) requiredExperience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDDExperience 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 requiredProject management experience preferredEmployee Benefits 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.Join Us! Apply today.Salary Range: $ 102,000 - $120,000 / annuallyPlease 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.SummaryLocation: Campbell, CA, United StatesType: Full TimeExperience: Mid LevelDepartment: Operations, Robotics