Sr Manufacturing Engineer, Capital Equipment

Imperative Care•Campbell, CA

4d•$125,000 - $145,000•Onsite

About The Position

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 Robotics 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.

Requirements

BS in Engineering or related discipline and 5+ years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry
Demonstrated knowledge and experience in pilot/production line set up and validation in controlled environment, including work under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, ISO 9001, and the MDD.
Familiar with GMP, GDP procedures and requirements
Ability to work independently or in team setting required

Nice To Haves

Experience with surgical robotics or other complex electromechanical capital equipment is highly desired

Responsibilities

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.
Complete projects related to in-house manufacturing, manufacturing engineering, and equipment planning/engineering in accordance the company’s Quality System and customer requirements.
Execute in-house and/or contract manufacturing activities and build relationships that ensure products are manufactured adhering to plans and quality/regulatory requirements.
Work with Supply Chain to ensure inventory of raw materials and components are available per planned build schedule, lead and be accountable for material issued to production/projects.
Develop manufacturing processes and Manufacturing Process Instructions (MPI’s) and lot history records (LHR’s) in collaboration with R&D and Quality.
Develop manufacturing specifications for products; coordinate all process validation activities with Quality- IQ/OQ/PQ.
Train/Certify MPI Trainer for manufacturing process instructions; may train other staff as needed.
Plan equipment and workflow layouts in manufacturing areas.
Manage manufacturing equipment design and development to ensure that equipment is cost effective and meets manufacturing specifications and maintain and coordinate all calibration and preventive maintenance activities in conformance with the Company’s Quality System requirements.