Plastics Engineer

Nanobiosym; Cambridge (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Nanobiosym in Cambridge, Massachusetts is seeking experienced Engineering candidates to enhance injection molded products and align manufacturing with FDA requirements. The ideal candidate has at least 7 years of relevant experience, a Master’s or Bachelor’s degree in Engineering, and proficiency with SolidWorks. Join our innovative team to contribute to the future of personalized medicine and healthcare delivery. Opportunities for advancement are available in a dynamic work environment.

Qualifications

• Minimum of 7 years experience in molding and manufacturing.
• Hands-on experience in medical device development in FDA-regulated environments.
• Proficiency with SolidWorks and CAD tools.

Responsibilities

• Enhance injection molded products and manufacturing processes.
• Create validation protocols aligned with FDA requirements.
• Lead troubleshooting and root cause analyses.

Skills

Lean methodologies

Problem-solving

Statistical analysis

Mechanical aptitude

Excellent communication

Education

Master's or Bachelor's degree in Engineering

Six Sigma Black Belt certification

Tools

SolidWorks

CAD tools

Job description

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