Staff Process Development Engineer jobs in United States
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Imperative Care · 2 months ago

Staff Process Development Engineer

Imperative Care is changing the way stroke is treated, focusing on developing breakthroughs in stroke care technologies. The Staff Process Development Engineer will lead product and process development projects for neuro-interventional medical devices, emphasizing robust manufacturing processes and collaboration with cross-functional teams.

Health CareMedicalMedical Device
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H1B Sponsor Likelynote

Responsibilities

Own the development of new processes and improvement of existing ones—driving definition, characterization, optimization, and validation
Identify, evaluate, and implement new process technologies that advance our manufacturing capabilities
Lead the design, qualification, and improvement of manufacturing equipment and fixturing
Plan, design, and mentor execution of DOEs to establish process windows, control limits, and workmanship standards
Apply DMAIC and other analytical methods to identify root cause, reduce variation, and drive robust solutions
Partner closely with R&D, QA/RA, and Operations to define manufacturable product specifications, visual standards, and workflows that ensure smooth transfer into production
Lead documentation of equipment and processes, ensuring compliance with best practices, quality system requirements, and regulatory standards
Participate in the management, development, and qualification of external supplier processes
Actively support our Quality Management System and promote a culture of rigor, safety, and continuous improvement

Qualification

Process DevelopmentProcess CharacterizationFDA Design ControlAnalytical MethodsEquipment DevelopmentData-Driven Problem SolvingCross-Functional CollaborationMolding ExperienceCritical ThinkingProject ManagementCommunication Skills

Required

BS in Engineering with 8+ years of related experience, or MS with 6+ years (medical device or other regulated industry preferred)
Strong background in process characterization, validation, and scale-up in a controlled environment
Skilled in analytical/statistical methods (DOE, SPC) with proficiency in Excel and Minitab
Solid knowledge of FDA Design Control, DFSS/DFM tools, GMP/GDP, and relevant standards (ISO 13485, FDA QSR)
Excellent critical thinking — able to connect cause and effect, prioritize under constraints, and deliver practical solutions
Experience in pilot and production line setup, validation, and scale-up
Proven ability to work independently and to lead/mentor others
Strong communication and project management skills
Ability to travel as required

Preferred

Molding experience is desirable

Benefits

A stake in our collective success with stock options
Competitive salaries
A 401k plan
Health benefits
Generous PTO
A parental leave program

Company

Imperative Care

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Imperative Care is singularly dedicated to finding meaningful answers to unsolved problems in stroke.

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 Stage
Total Funding
$558.97M
Key Investors
Ally Bridge GroupD1 Capital Partners
2024-07-25Series E· $150M
2021-07-15Series D· $260M
2021-01-01Debt Financing· $40M

Leadership Team

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Lara Abbaschian
Senior Director, R&D
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Company data provided by crunchbase