Nanobiosym is on the cusp of rewriting the rules of personalized medicine, novel technologies, and healthcare delivery. Founded by a renowned MIT and Harvard trained Physician and Physicist, Nanobiosym's innovative pipeline of products leverage novel advances in physics, biomedicine, and nanotechnology. Awarded the first ever X-PRIZE for healthcare, and a recipient of multiple other prestigious peer-reviewed funding awards, Nanobiosym is currently adding to its talented team as it expands into a global commercial enterprise. We are currently seeking Engineering candidates to add to our growing team.
RESPONSIBILITIES
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Partner with colleagues and leadership to enhance and refine injection molded and assembled products, as well as the processing across multiple manufacturing stages.
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Create and roll out validation protocols (IQ/OQ/PQ) aligned with FDA requirements.
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Lead troubleshooting efforts and guide the team through detailed root cause analyses.
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Apply Lean methodologies to engineer inventive, comprehensive, and workable technical solutions.
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Serve in a hands-on capacity where versatility is essential and advancement opportunities emerge quickly.
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Leverage Lean principles to design creative, thorough, and pragmatic engineering solutions.
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Oversee debugging, packaging, and sterilization activities.
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Contribute to cross-functional initiatives aimed at elevating safety, quality, efficiency, and total productivity.
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Track and validate current injection molding processes and tooling to identify and implement continuous improvement initiatives.
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Record modifications to processes and equipment through the change management system.
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Pinpoint risks, assess technical alternatives and value propositions, and advocate for optimal solutions.
REQUIRED QUALIFICATIONS
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Master's or Bachelor's degree in Engineering (Plastics or Mechanical disciplines preferred)
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Six Sigma Black Belt certification is a plus
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A minimum of 7 years working with molding, micro molding, mold flow, mold-making, and tooling in a manufacturing setting
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At least 7 years of hands-on experience spanning various technical areas, materials, manufacturing, and product design
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Current experience in medical device development within an FDA-regulated (21 CFR 820) and/or ISO 13485 environment
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Background in design enhancement and proficiency with SolidWorks/CAD tools
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Working knowledge of statistical analysis and statistical process control
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Excellent written and oral communication abilities, along with strong documentation and organizational skills
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Demonstrated mechanical aptitude
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A genuine enthusiasm for problem-solving, with the ability to juggle competing priorities and excel in a fast-moving workplace
