Staff Process Development Engineer

Staff Process Development Engineer

This position is based in our Campbell, California offices. This position is hybrid and full time.

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. The position requires someone who thrives on solving complex problems, applying structured engineering approaches, and translating design requirements into practical, manufacturable solutions. Work will span from early concept development through scale-up, with heavy emphasis on process characterization (DOEs, data analysis), equipment and fixturing design, and rigorous documentation.

Process Development: Own the development of new processes and improvement of existing ones—driving definition, characterization, optimization, and validation.

Technology Innovation: Identify, evaluate, and implement new process technologies that advance our manufacturing capabilities.

Equipment Development: Lead the design, qualification, and improvement of manufacturing equipment and fixturing.

Process Characterization: Plan, design, and mentor execution of DOEs to establish process windows, control limits, and workmanship standards.

Data-Driven Problem Solving: Apply DMAIC and other analytical methods to identify root cause, reduce variation, and drive robust solutions.

Cross-Functional Collaboration: Partner closely with R&D, QA/RA, and Operations to define manufacturable product specifications, visual standards, and workflows that ensure smooth transfer into production.

Documentation & Control: Lead documentation of equipment and processes, ensuring compliance with best practices, quality system requirements, and regulatory standards.

Supplier Engagement: Participate in the management, development, and qualification of external supplier processes.

Culture & Quality: Actively support our Quality Management System and promote a culture of rigor, safety, and continuous improvement.

What You'll Bring:

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.

Molding experience is desirable.

Ability to travel as required.

Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.

Salary Range: $157,000 – 167,000/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.