- Work/lead collaboratively but act autonomously to develop new processes and improve existing processes.
- Will participate/initiate innovating, identifying, and selecting new process technologies.
- Will oversee/lead definition, development and qualification of new equipment/fixturing or improving existing equipment/ fixturing.
- Will oversee/lead all stages of process design including definition, selection, characterization, optimization, and validation.
- Will oversee/lead project teams to develop process windows, manufacturing control limits and workmanship standards.
- Will participate/lead projects to define manufacturable product design specifications and visual standards.
- Will plan/oversee/mentor the design, execution, test, and analysis of results from DOEs.
- Will apply/oversee/mentor application of DMAIC principles to make data-driven decisions, solve problems and find root cause.
- Will lead equipment and process documentation ensuring adherence to best practices.
- Will collaborate with/lead cross functional teams to develop manufacturing workflows, effectivity monitoring control plans, lot history records.
- Will collaborate with/lead 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.
- Will plan and mentor application of analytical techniques and apply engineering principles to understand the impact and interaction of materials and processes on process and product outputs.
- Will participate/oversee managing and qualifying processes/components from external suppliers.
- BS in Engineering or related discipline and 8+ years of related experience; or MS in Engineering with 6+ years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry
- Able to perform/oversee computer modeling simulations to determine the effects of design, materials, and process on the functional and reliability performance of the final product 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, prioritise 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 team setting and mentor/manage.
- Ability to travel – as required.
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Staff Process Development Engineer - Campbell, United States - Imperative Care
Description
Job Title: Staff Process Development Engineer
Location: This position is based in our Campbell, California offices. This position is On-site and 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
This position will lead product development projects defining, characterizing, optimizing, and validating stable, robust, and capable processes for neuro-interventional medical devices. They will lead improvement and development of internal equipment and processes and may participate in the management and qualification of processes at external suppliers/contract manufacturers. Responsibilities will include creative problem solving, strategic critical thinking, application of engineering principles to plan and design process characterization studies/DOEs, analyzing, interpreting, and documenting/reporting data, and documenting equipment/processes.
What You'll Bring
Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.
Join Us Apply Today.
Salary Range: $144,000 – 154,000 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.
