Imperative Care · 10 hours ago
Principal Process Development Engineer
Campbell, CA
Full-time
Onsite
Lead/Staff
$177K/yr - $185K/yr
12+ years expImperative Care is changing the way stroke is treated, developing breakthroughs that will revolutionize stroke care. They are seeking a Principal Process Development Engineer to lead process design initiatives for intra-vascular medical devices, ensuring robust and capable processes for commercialization.
Health CareMedicalMedical Device
Responsibilities
Oversee all stages of process design, including definition, selection, characterization, optimization and (re)validation for new product launches and existing commercial products, acting as a subject matter expert (SME)
Lead collaborative efforts to research, define and develop and improve new and existing processes, establishing methods and techniques with company-wide impact, including creating process windows, manufacturing control limits and workmanship standards
Spearhead innovation by individually or collaboratively identifying and selecting new process technologies, demonstrating expert-level professionalism
Lead and oversee the development, documentation and qualification of new or existing equipment and fixturing, directing process tasks and potentially personnel
Direct and mentor the design, execution, test, analysis and interpretation of results from DOEs, advising on best practices and processes and leading the application of DMAIC principles to make data-driven decisions, find root cause and solve complex problems
Oversee equipment and process documentation architecture, ensuring adherence to best practices and collaborate with cross functional teams to develop manufacturing systems and architecture, facilitating efficient workflows, effectivity monitoring control plans and lot history records
Lead cross-functional team members 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 the product, while teaching analytical techniques and applying engineering principles to understand the impact and interaction of materials and processes on process and product outputs
Provide technical subject matter expertise in projects that define manufacturable product design specifications and visual standards and oversee management and partnership with external suppliers by executing due diligence assessments, setting specifications for critical quality and manufacturing attributes (CQA, CMA) for materials and components and collaborating on development projects and the qualification/validation of external processes
Qualification
Required
Bachelor's degree in engineering, or related discipline, and a minimum of 12+ years of related experience; or equivalent combination of education and experience
Ability to perform/oversee complex computer modelling simulations to determine the effects of design, materials, and process on the functional and reliability performance of the final product
SME Experience with pilot/production line set-up, validation and scale-up in a controlled environment
Superior analytical and statistical skills (SPC, DOEs) using Excel, Minitab &/or JMP
Deep knowledge and experience in FDA Design Control procedures and DFSS/DFM tools
Exceptional project management and communications skills (both written and verbal) including Agile scrum frameworks
Exceptional critical thinking and complex problem-solving skills – able to intuitively identify problems, logically and empirically associate cause and effect, and under a variety of perspectives and constraints, prioritise and provide creative, effective, practical and strategical solutions
Expert knowledge in application of Engineering Principles, DMAIC methodology and medical device industry best practices
Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, the MDD, and knowledge of relevant standards
Expert knowledge of GMP, GDP procedures and requirements
Ability to work independently, lead others and influence/mentor teams, including across functionally
Ability to travel – as required
Preferred
Master's degree; or PhD may be considered as part of related work experience
Benefits
Stock options
Bonus
Competitive salaries
A 401k plan
Health benefits
Generous PTO
Parental leave program
Company
Imperative Care
Imperative Care is singularly dedicated to finding meaningful answers to unsolved problems in stroke.
201-500 employees
H1B Sponsorship
Imperative Care has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (3)
2023 (5)
2021 (1)
Funding
Current Stage
Late StageTotal Funding
$558.97MKey Investors
Ally Bridge GroupD1 Capital Partners
2024-07-25Series E· $150M
2021-07-15Series D· $260M
2021-01-01Debt Financing· $40M
Leadership Team
Lara Abbaschian
Senior Director, R&D
Recent News
BioWorld Financial Watch
2025-09-24
Company data provided by crunchbase