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.