Title: Manufacturing Engineer I, Capital Equipment
This position is based in our Campbell, California offices. This position is on-site & full-time

What You'll Do
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

What You'll Bring

• 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.

Employee 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: $90,000 - 100,000 / 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.