Staff Process Development Engineer, Electromechanical Consumables

Imperative Care • Campbell, CA

5d • 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
An individual contributor in this role, uses advanced expertise to plan and design process characterization studies and DOEs, analyze, interpret, and document/report relevant data improve performance of equipment and processes. This position will lead product development projects through the definition, characterization, optimizations, and validation of stable, robust, and capable processes for neuro-interventional medical devices. This role will develop and implement improvements approved for optimum performance of internal equipment and processes, spearheading the administration and qualification of processes at external suppliers/contract manufacturers.
Oversee performance and improvements across all stages of process design, working collaboratively with cross-functional teams to design, characterize, optimize, document, and control all manufacturing processes by defining and measuring critical process parameters (CPP) that impact critical quality attributes (CQA) of a product.
Act autonomously to develop new processes and improve existing processes, spearheading innovation by identifying and selecting new process technologies.
Initiate definition, development, improvement and qualification of new/existing equipment/fixturing and develop process windows, manufacturing control limits, workmanship standards, manufacturable product design specifications and visual standards.
Lead equipment and process documentation activities ensuring adherence to best practices and collaborate with/lead cross functional teams to develop manufacturing workflows, effectivity monitoring control plans, lot history records.
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.

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
• Ability to perform/oversee complex computer modeling simulations to determine the effects of design, materials, and process on the functional and reliability performance of the final product
• Extensive experience with pilot/production line set-up, validation/scale-up in a controlled environment
• Advanced knowledge and experience in FDA Design Control procedures and DFSS/DFM tools
• Exceptional critical thinking, and problem-solving skills – able to intuitively identify problems, logically and empirically to associate cause and effect, and under a variety of perspectives and constraints, prioritise and provide creative, effective, practical and strategical solutions
• Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, the MDD, and knowledge of relevant standards. And strong knowledge of GMP, GDP procedures and requirements

Responsibilities

• Plan and design process characterization studies and DOEs
• Analyze, interpret, and document/report relevant data improve performance of equipment and processes
• Lead product development projects through the definition, characterization, optimizations, and validation of stable, robust, and capable processes for neuro-interventional medical devices
• Develop and implement improvements approved for optimum performance of internal equipment and processes, spearheading the administration and qualification of processes at external suppliers/contract manufacturers
• Oversee performance and improvements across all stages of process design
• Work collaboratively with cross-functional teams to design, characterize, optimize, document, and control all manufacturing processes by defining and measuring critical process parameters (CPP) that impact critical quality attributes (CQA) of a product
• Act autonomously to develop new processes and improve existing processes, spearheading innovation by identifying and selecting new process technologies
• Initiate definition, development, improvement and qualification of new/existing equipment/fixturing and develop process windows, manufacturing control limits, workmanship standards, manufacturable product design specifications and visual standards
• Lead equipment and process documentation activities ensuring adherence to best practices and collaborate with/lead cross functional teams to develop manufacturing workflows, effectivity monitoring control plans, lot history records
• 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

Benefits

• Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, bonus, health benefits, generous PTO, and a parental leave program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level