The Process Development Engineer II supports product development for neuro-interventional medical devices by optimizing and validating manufacturing processes and collaborating with cross-functional teams.
Title: Process Development Engineer II
Location: This position is based in our Campbell, California office. This position is full time and on site
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
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.
What You’ll Bring
Excellent analytical and statistical skills (SPC, DOEs) using Excel, Minitab &/or JMP with strong ability to prioritize and provide creative, effective and practical solutions.
Salary Range: $95,000 – 106,000/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
Location: This position is based in our Campbell, California office. This position is full time and on site
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
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.
What You’ll Bring
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.
Salary Range: $95,000 – 106,000/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
Top Skills
Excel
Fda Qsr
Iso 13485
Jmp
Minitab
Imperative Care Campbell, California, USA Office
Dell Ave, Campbell, CA, United States, 95008
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