Manufacturing Engineer II, Capital Equipment

Imperative Care•Campbell, CA

9d•$102,000 - $120,000•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 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

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.
Familiar with GMP, GDP procedures and requirements.
Ability to work independently or in team setting required.

Nice To Haves

Experience in pilot/production line set-up, validation in a controlled environment is preferred.
Project management experience preferred.

Responsibilities

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.
Completes projects related to in-house manufacturing, manufacturing engineering, and equipment planning/engineering in accordance the company’s Quality System and customer requirements.
Assists in the construction of prototypes for new products/processes or current product enhancements.
Provides support to in-house manufacturing activities to verify products are manufactured in accordance with product plans and quality/regulatory requirements.
Works with Supply Chain to verify inventory of raw materials and components are available per the planned build schedule, monitors and is accountable for material issued to production/projects.
Develops 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.
Conducts time studies for each manufacturing process and identifies process development initiatives.
Works with Quality personnel to define in-process inspections and testing and resolves quality and yield issues through continuous improvement projects.
Informs and coordinates with multi-functional operations project team activities from early project conceptualization through clinical testing.
Completes, maintains, and monitors manufacturing tasks of project schedule, and ensures that critical timelines and/or budgets are established and met.
Participates in manufacturing team meetings to ensure communication between members.
Builds positive proactive working relationships with team members and other staff members.
Completes manufacturing specifications for products; coordinates all process validation activities with Quality- IQ/OQ/PQ.
Determines tooling and equipment needs for the timely and cost-effective manufacture of products.
Works 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.
Collaborates with suppliers to ensure parts/services are properly documented and meet specifications.
Reviews specifications for sub and final assemblies.
Supports manufacturing line and approves DCO’s for manufacturing engineering.
Supports the training/certification of the MPI Trainer for manufacturing process instructions; may train other staff as needed.
Using continuous improvement techniques, works with Quality Assurance to identify and implement programs to drive down cost and improve yield and reliability.