Sr Process Development Engineer

Job Title: Sr Process Development Engineer

Location: This position is based in our Campbell, California offices. This position is on-site & full time.

Why Imperative Care?

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

The Senior Process Development (PD) Engineer will participate in product development projects defining, characterizing, optimizing, and validating stable, robust, and capable processes for neuro-interventional medical devices. They will participate/lead improvement and development of internal equipment and processes and may participate in qualification of processes at external suppliers/contract manufacturers. Responsibilities will include creative problem solving, strategic critical thinking, application of engineering principles to design process characterization studies, analyzing, interpretation and documenting/reporting data, and documenting equipment/processes.

• Work collaboratively but act autonomously to develop new processes and improve existing processes.
• May participate/initiate innovating, identifying, and selecting new process technologies.
• Work on/lead defining, developing, and qualifying new equipment/fixturing or improving existing equipment/ fixturing.
• Participate/lead in various stages of process design including definition, selection, characterization, optimization, and validation.
• Work/lead project teams to develop process windows, manufacturing control limits and workmanship standards.
• Participate/lead in projects to define manufacturable product design specifications and visual standards.
• Participate/lead in the design, execution, test, and analysis of results from DOEs.
• Plan and apply DMAIC principles to make data-driven decisions, solve problems and find root cause.
• Work on equipment and process documentation.
• Collaborate with cross functional teams to develop manufacturing workflows, effectivity monitoring control plans, lot history records.
• Collaborate with cross-functional team members to design, characterize, optimize, document, and control all manufacturing processes through the definition and measurement of critical process parameters (CPP) which impact critical quality attributes (CQA) of the product.
• Employ analytical techniques and apply engineering principles to understand the impact and interaction of materials and processes on process and product outputs.
• May participate in managing and qualifying external suppliers.
• Inform responsible personnel of concerns involving product quality

What You’ll Bring

• BS in Engineering or related discipline and 5+ years of related experience; or MS in Engineering with 3+ years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry
• Able to perform computer modelling simulations on material, process & properties a plus.
• Experience in pilot and production line set-up, validation and scale-up in a controlled environment.
• Excellent analytical and statistical skills (SPC, DOEs) using Excel, Minitab &/or JMP.
• Excellent knowledge and experience in FDA Design Control procedures and DFSS/DFM tools.
• Excellent project management and communications skills (both written and verbal). Agile scrum framework preferred.
• Exceptional critical thinking – able to intuitively identify problems, logically and empirically associate cause and effect, and under a variety of perspectives and constraints, prioritize and provide creative, effective and practical solutions.
• Excellent working knowledge and application of DMAIC methodology.
• 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.
• Ability to work independently or in a team setting and mentor/manage.
• Ability to travel – as required.

Salary Range: $116,000 - 127,000 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. As part of our total rewards package, Imperative Care offers comprehensive benefits including a 401k plan, health benefits, generous PTO, a parental leave program and emotional health resources.