Staff Manufacturing Engineer, Capital Equipment

Imperative Care • Campbell, CA

2d • Onsite

About The Position

This position is based in our Campbell, California offices. This position is on-site & full-time

Why 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 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.

What You’ll Do
This position is responsible for the following areas: In-House and Contracted Manufacturing, Manufacturing Engineering, and Equipment Planning/Engineering in accordance the company’s Quality System and customer requirements. This position will ensure that assigned projects product/s are designed to facilitate manufacturability and will be responsible for technology transfer to manufacturing and, ultimately, scalability for commercialization for Telos’ robotic system. This position may be an individual technical innovation contributor or, as needed, supervise a technical team with responsibility for mentorship and development of other MFG engineers.
As a technical individual contributor, oversee the builds for capital hardware and equipment.
Manage in-house and contract manufacturing activities and relationships to ensure products are manufactured in accordance with product plans and quality/regulatory requirements.
Ensure Supply Chain is aware of inventory, raw materials, and component requirements per the planned build schedule; manage and be accountable for material issued to production or engineering projects.
Conceptualize and implement manufacturing improvements, tooling, and systems to increase productivity and/or improve yields.
Define manufacturing or process related technologies to reduce manual operations and/or improve repeatability.
Participate in the selection of suppliers for manufacturing components.
Work closely with Quality to create manufacturing and process related SOPs and Wis.
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 Quality.
Perform time studies for each manufacturing process and identify process development initiatives.
Ensure that all products are manufactured in compliance with the company Quality System, customer needs, budgetary requirements, schedule requirements, and the regulatory requirements.
Work with Quality personnel to define in-process inspections and testing and resolve quality and yield issues through continuous improvement projects.

Requirements

• BS in Engineering or related discipline and 8+ years of related experience; or MS in Engineering with 8+ years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry
• Knowledge of and experience in pilot/production line set up and validation in Controlled Environment.
• Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, the MDD, and knowledge of relevant standards.
• Ability to detail project plans effectively.
• Familiar with GMP, GDP procedures and requirements.
• Familiar with Design Control procedures and requirements.
• Excellent communications skills (both written and verbal) required.
• Ability to work independently or in team setting required.
• Working knowledge of quality system requirements and compliance (e.g. traceability, QSRs, ISO, MDD/MDR requirements) and other applicable regulations.
• Experience working with ERP/MRP/Documentation control systems

Nice To Haves

• Project management experience preferred.

Responsibilities

• Oversee the builds for capital hardware and equipment.
• Manage in-house and contract manufacturing activities and relationships to ensure products are manufactured in accordance with product plans and quality/regulatory requirements.
• Ensure Supply Chain is aware of inventory, raw materials, and component requirements per the planned build schedule; manage and be accountable for material issued to production or engineering projects.
• Conceptualize and implement manufacturing improvements, tooling, and systems to increase productivity and/or improve yields.
• Define manufacturing or process related technologies to reduce manual operations and/or improve repeatability.
• Participate in the selection of suppliers for manufacturing components.
• Work closely with Quality to create manufacturing and process related SOPs and Wis.
• 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 Quality.
• Perform time studies for each manufacturing process and identify process development initiatives.
• Ensure that all products are manufactured in compliance with the company Quality System, customer needs, budgetary requirements, schedule requirements, and the regulatory requirements.
• Work with Quality personnel to define in-process inspections and testing and resolve quality and yield issues through continuous improvement projects.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees