Staff Process Development Engineer

Imperative Care • Campbell, CA

105d • $157,000 - $167,000

About The Position

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. This role will take the lead on product and process development projects for neuro-interventional medical devices, with a focus on building stable, robust, and capable manufacturing processes. The scope includes defining, characterizing, optimizing, and validating processes, as well as driving equipment development and improvements internally and at supplier/contract manufacturer sites.

Requirements

• 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.

Nice To Haves

• Molding experience is desirable.
• Ability to travel as required.

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.

Benefits

• Stock options
• Competitive salaries
• 401k plan
• Health benefits
• Generous PTO
• Parental leave program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 251-500 employees