Process Development Engineer II

Title

Process Development Engineer II

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

A developing professional in this position will provide input to product development projects related to defining, characterizing, optimizing, and validating stable, robust, and capable processes for neuro-interventional medical devices. This position will analyze and identify opportunities for the improvement of internal equipment and processes. This role uses prior experience, learned engineering principles, critical thinking and creative problem‑solving skills to evaluate processes and equipment performance.

• Collaborate with cross‑functional teams to define, characterize, optimize, validate, document, and control manufacturing processes by identifying and measuring critical process parameters (CPP) that impact critical quality attributes (CQA) of a product.
• Perform process characterization studies to validate, improve, or establish processes or equipment to deliver a quality product consistently.
• Collect, analyze and interpret data to document equipment performance and process outputs.
• Define, develop, and qualify new equipment/fixtures or improve existing equipment/fixtures.
• May participate in innovating, identifying, and selecting new process technologies.

Excellent analytical and statistical skills (SPC, DOEs) using Excel, Minitab &/or JMP with strong ability to prioritize and provide creative, effective and practical solutions.

• Exceptional critical thinking skills with strong ability to intuitively identify problems, logically and empirically, and associate cause and effect under a variety of perspectives and constraints.
• Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, the MDD, and knowledge of relevant standards.
• Familiar with GMP, GDP procedures and requirements.
• Excellent project management and communications skills (both written and verbal).
• Ability to complete routine tasks independently and contribute to initiatives in a team setting.
• Professional experience in the medical device or related regulated industry is preferred.

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.

$95,000 – 106,000 annually

Note:

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

External recruiter policy:
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.