Title: Staff Process Development EngineerThis position is based in our Campbell, California offices. This position is on-site & full-timeWhy 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.
What You’ll Bring: - 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.
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.Join Us! Apply today.Salary Range: $147,000 – 167,000 /annuallyPlease 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. The use of external recruiters/staffing agencies requires prior approval from our Human Resources Department. The Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with Imperative Care.
Imperative Care will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external recruiter/staffing agency does not create any implied obligation on the part of Imperative Care.