Engineering Position At Nanobiosym 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:
Partner with colleagues and leadership to enhance and refine injection molded and assembled products, as well as the processing across multiple manufacturing stages.
Create and roll out validation protocols (IQ/OQ/PQ) aligned with FDA requirements.
Lead troubleshooting efforts and guide the team through detailed root cause analyses.
Apply Lean methodologies to engineer inventive, comprehensive, and workable technical solutions.
Serve in a hands-on capacity where versatility is essential and advancement opportunities emerge quickly.
Leverage Lean principles to design creative, thorough, and pragmatic engineering solutions.
Oversee debugging, packaging, and sterilization activities.
Contribute to cross-functional initiatives aimed at elevating safety, quality, efficiency, and total productivity.
Track and validate current injection molding processes and tooling to identify and implement continuous improvement initiatives.
Record modifications to processes and equipment through the change management system.
Pinpoint risks, assess technical alternatives and value propositions, and advocate for optimal solutions.
Required Qualifications:- Master's or Bachelor's degree in Engineering (Plastics or Mechanical disciplines preferred)
- Six Sigma Black Belt certification is a plus
- A minimum of 7 years working with molding, micro molding, mold flow, mold-making, and tooling in a manufacturing setting
- At least 7 years of hands-on experience spanning various technical areas, materials, manufacturing, and product design
- Current experience in medical device development within an FDA-regulated (21 CFR 820) and/or ISO 13485 environment
- Background in design enhancement and proficiency with SolidWorks/CAD tools
- Working knowledge of statistical analysis and statistical process control
- Excellent written and oral communication abilities, along with strong documentation and organizational skills
- Demonstrated mechanical aptitude
- A genuine enthusiasm for problem-solving, with the ability to juggle competing priorities and excel in a fast-moving workplace
