Lead process design and implementation of medical device production, ensuring effective methods and technologies are utilized for commercialization. Provide expertise and guidance on project management and compliance with quality systems.
Job Title: Principal Process Development Engineer
Location: This position is based in our Campbell, California offices. This position is full time.
Why Imperative Care?
Do you want to make a real impact on patients? Imperative Care is changing the way stroke is treated. As part of our team, you’d be developing breakthroughs that will revolutionize the future of stroke care. Every day, the technologies that we develop at Imperative Care directly impact human lives. Our focus is on the needs of the patient, and they come first in everything we do.
What You’ll Do
As a subject matter expert, an individual in this position will plan, establish and lead implementation of process design initiatives and projects for developing products to define, characterize, optimize, and validate stable, robust, and capable processes for the commercialization of intra-vascular medical devices. This role will advise teams, with broad scope of discretion, on projects that develop, improve and qualify internal equipment and processes and oversee the administration and qualification of processes at external suppliers and contract manufacturers. As a strategic and creative problem solver, an individual in this role will use deep knowledge and superior critical thinking skills to plan and execute DOEs and process characterization studies, leading the analysis, validation, interpretation, documentation and reporting of data.
What You’ll Bring
Join Us! Apply Today.
Salary Range: $182,000 – 192,000 /annually
Please 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.
Location: This position is based in our Campbell, California offices. This position is full time.
Why Imperative Care?
Do you want to make a real impact on patients? Imperative Care is changing the way stroke is treated. As part of our team, you’d be developing breakthroughs that will revolutionize the future of stroke care. Every day, the technologies that we develop at Imperative Care directly impact human lives. Our focus is on the needs of the patient, and they come first in everything we do.
What You’ll Do
As a subject matter expert, an individual in this position will plan, establish and lead implementation of process design initiatives and projects for developing products to define, characterize, optimize, and validate stable, robust, and capable processes for the commercialization of intra-vascular medical devices. This role will advise teams, with broad scope of discretion, on projects that develop, improve and qualify internal equipment and processes and oversee the administration and qualification of processes at external suppliers and contract manufacturers. As a strategic and creative problem solver, an individual in this role will use deep knowledge and superior critical thinking skills to plan and execute DOEs and process characterization studies, leading the analysis, validation, interpretation, documentation and reporting of data.
- 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.
What You’ll Bring
- Bachelor’s degree in engineering, or related discipline, and a minimum of 12+ years of related experience; or equivalent combination of education and experience.
- Master’s degree; or PhD may be considered as part of related work 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.
Join Us! Apply Today.
Salary Range: $182,000 – 192,000 /annually
Please 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.
Imperative Care Campbell, California, USA Office
Dell Ave, Campbell, CA, United States, 95008
Similar Jobs
Healthtech • Pharmaceutical
Lead technology projects and develop advanced tissue manufacturing processes for heart valve devices, ensuring regulatory compliance and optimizing production. Mentor engineers and enhance organizational capabilities.
Top Skills:
AIAutomationChemical ProcessingData AnalyticsLaser TechnologiesMechanical DesignVision Systems
Energy
The Principal Process Development Engineer will lead the development, testing, and integration of proprietary equipment in collaboration with design teams, ensuring process capability and overseeing equipment build.
Top Skills:
Battery ManufacturingEquipment DesignHigh-Volume Thin CeramicsManufacturingProcess DevelopmentR&DSolar Manufacturing
eCommerce • Fashion • Retail • Sales • Wearables • Design
Provide personalized styling and sales support in-store: greet customers, recommend complete looks, drive purchases, perform POS transactions, maintain stockroom organization, and assist with store operations. Must lift up to 50 lbs and work flexible schedules including nights, weekends, and holidays.
What you need to know about the San Francisco Tech Scene
San Francisco and the surrounding Bay Area attracts more startup funding than any other region in the world. Home to Stanford University and UC Berkeley, leading VC firms and several of the world’s most valuable companies, the Bay Area is the place to go for anyone looking to make it big in the tech industry. That said, San Francisco has a lot to offer beyond technology thanks to a thriving art and music scene, excellent food and a short drive to several of the country’s most beautiful recreational areas.
Key Facts About San Francisco Tech
- Number of Tech Workers: 365,500; 13.9% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Google, Apple, Salesforce, Meta
- Key Industries: Artificial intelligence, cloud computing, fintech, consumer technology, software
- Funding Landscape: $50.5 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Sequoia Capital, Andreessen Horowitz, Bessemer Venture Partners, Greylock Partners, Khosla Ventures, Kleiner Perkins
- Research Centers and Universities: Stanford University; University of California, Berkeley; University of San Francisco; Santa Clara University; Ames Research Center; Center for AI Safety; California Institute for Regenerative Medicine
