Principal Process Development Engineer

Imperative Care is seeking a Principal Process Development Engineer to develop breakthroughs that will revolutionize the future of stroke care. The role will involve planning, establishing, and leading implementation of process design initiatives and projects for developing products to define, characterize, optimize, and validate stable, robust, and capable processes for the commercialization of intra-vascular medical devices.

Requirements

• Bachelor’s degree in engineering, or related discipline, and a minimum of 12+ years of related experience
• Master’s degree; or PhD may be considered as part of related work experience
• Ability to perform/oversee complex computer modelling simulations to determine the effects of design, materials, and process on the functional and reliability performance of the final product
• SME Experience with pilot/production line set-up, validation and scale-up in a controlled environment
• Superior analytical and statistical skills (SPC, DOEs) using Excel, Minitab &/or JMP
• Deep knowledge and experience in FDA Design Control procedures and DFSS/DFM tools
• Exceptional project management and communications skills (both written and verbal) including Agile scrum frameworks
• Exceptional critical thinking and complex problem-solving skills
• Expert knowledge in application of Engineering Principles, DMAIC methodology and medical device industry best practices
• Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, the MDD, and knowledge of relevant standards
• Expert knowledge of GMP, GDP procedures and requirements

Benefits

• Stock options
• Bonus
• Competitive salaries
• 401k plan
• Health benefits
• Generous PTO
• Parental leave program