Process Development Engineer

Process Development Engineer I

Location: Campbell, CA (full time, on‑site)

Do you want to make a real impact on patients? Imperative Care is changing the way stroke and vascular diseases are treated. As part of our team, you’d be supporting 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.

As a new professional in this field, a Process Development Engineer I will participate in defining, characterizing, optimizing, and validating processes for product development of intravascular medical devices. This role will use basic professional knowledge, critical thinking, and creative problem‑solving skills to assist in improving internal equipment, applying engineering principles, conducting process studies, analyzing project data, and documenting equipment/processes.

• Assist cross‑functional teams in designing, characterizing, optimizing, documenting, and controlling all manufacturing processes through the definition and measurement of critical process parameters (CPP) which impact critical quality attributes (CQA) of the product.
• Participate in Design of Experiments (DoE) and DMAIC projects to help design, execute, test, analyse, problem‑solve and find root cause when evaluating changes/improvements to a process or design.
• Collaborate effectively and work independently to complete tasks after receiving detailed instructions.
• Support teams that create process windows, manufacturing control limits, and workmanship standards.
• Participate in projects to define manufacturable product design specifications and visual standards.
• Monitor equipment and documentation processes.
• Build relationships with cross‑functional teams that develop manufacturing workflows, monitor control plan effectiveness and lot history records.
• Maintain professional knowledge of analytical techniques and engineering principles applications to collect and analyze data and understand the impact and interaction of materials and processes on process and product outputs.

• Bachelor’s degree in engineering or related field, and less than 2 years of any other professional experience; or equivalent combination of education and work experience.
• Professional experience in the medical device industry is preferred.
• Excellent analytical and statistical skills (SPC, DOEs) using Excel, Minitab & or JMP.
• Ability to identify problems, logically and empirically, and associate cause‑effect relationships under a variety of perspectives and constraints.
• Ability to prioritise and provide creative, effective and practical solutions.
• Strong communication skills (both written and verbal).
• Experience in pilot/production line set‑up, validation in a controlled environment is preferred.
• Knowledge of quality systems design to meet governmental regulations such as FDA QSR, ISO 13485, the MDD, and knowledge of relevant standards is desired.
• Basic knowledge or experience with FDA Design Control procedures and DFSS/DFM tools a plus.
• Ability to perform computer modelling simulations on material, process & properties a plus.
• Familiar with GMP, GDP procedures and requirements.

Includes a stake in our collective success with stock options, bonus, competitive salaries, a 401(k) plan, health benefits, generous PTO, and a parental leave program.

$90,000 – $95,000 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 will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external recruiter/staffing agency does not create any implied obligation on the part of Imperative Care.