Job Description

Title: Sr Process Development Engineer
Location This position is full time and on-site in Campbell, CA

Why Imperative Care?
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.

What You’ll Do
As a senior professional in this field, this position will contribute to product development projects by defining, characterizing, optimizing, and validating stable, robust, and capable processes for neuro-interventional medical devices. This role will develop and improve internal equipment and manufacturing processes including qualification of processes at external suppliers/contract manufacturers sites. This position uses demonstrated experience to contribute to design process characterization studies by analyzing, interpreting and documenting/reporting data, and documenting effectiveness of equipment/processes.

• Prepare and implement improvements to the design, selection, characterization, optimization, validation, documentation, and control all manufacturing processes. Define and measure critical process parameters (CPP) that impact critical quality attributes (CQA) of a product, along with cross-functional teams.
• Spearhead the development and improvement of new/existing processes.
• Initiate innovation by identifying and selecting new process technologies including defining, developing, and qualifying new equipment/fixtures or improving existing equipment/ fixtures.
• Identify and recommend solutions to improve performance by employing analytical techniques and engineering principles to understand impact/interaction of materials and processes on outputs.
• Develop with a cross-functional team process windows, manufacturing control limits, manufacturing workflows, effectively monitoring control plans, lot history records and workmanship standards.
• Define manufacturable product design specifications and visual standards.
• Design, execute, test, and analyze results from DOEs providing guidance/insights to collaborating team.
• Plan and make data-driven decisions by applying DMAIC principles to find root cause/solve problems.
• Document equipment and process performance and compliance.
• Participate in overseeing and qualifying external suppliers

What You’ll Bring

• Bachelor’s degree in engineering or related discipline and a minimum of 5 years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry.
• Ability to perform computer modelling simulations on material, process & properties.
• Experience in pilot and production line set-up, validation and scale-up in a controlled environment.
• Experience with GMP, GDP procedures and requirements.
• Excellent analytical and statistical skills (SPC, DOEs) using Excel, Minitab &/or JMP.
• Excellent knowledge of and experience in FDA Design Control procedures and DFSS/DFM tools.
• Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, the MDD, and knowledge of relevant standards.
• Excellent project management and communications skills (both written and verbal).
• Exceptional critical thinking – 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, and practical solutions.
• Working knowledge of Agile scrum framework, a plus.
• Ability to work independently and influence others in team setting with/without authority.
• Able to share knowledge and mentor/guide others in work related to this filed.
• Ability to travel – as required.

Employee Benefits include a stake in our collective success with stock options, bonus, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.
Salary Range: $125,000 – 136,000 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
Join Us! Imperative Care

The use of external recruiters/staffing agencies requires prior approval from our Human Resources Department. The Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with Imperative Care.

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.