25 Apr Imperative Care, Principal Process Development Engineer
What You’ll Do
Plan and lead process design initiatives and projects for developing products to define, characterize, optimize, and validate stable, robust and capable processes for the commercialization of neuro-interventional medical devices. Lead teams and/or projects to develop, improve and qualify internal equipment and processes. Oversee management and processes at external suppliers and contract manufacturers.
- Lead collaborative efforts to research, define and develop new processes and improve existing processes.
- Lead all stages of process design including definition, selection, characterization, optimization & (re)validation for new product launches and supporting commercial products.
- Lead projects to develop process windows, manufacturing control limits and workmanship standards, as well as defining manufacturable product design specifications and visual standards.
- Collaborate with teams to develop systems and architecture for efficient workflows, effectively monitoring control plans and lot history records. Oversee equipment and process documentation architecture.
What You’ll Bring
- BS in Engineering or related discipline and 12+ years of related experience; or MS in Engineering with 8+ years of related experience; or equivalent combination of education and experience in the medical device or other regulated industry
- 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.
- Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, the MDD, and knowledge of relevant standards. Familiarity with GMP, GDP procedures and requirements.
- 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.
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.
Salary Range: $170,000 – 177,000 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.