Senior Chemical Process Engineer

3 days ago


Marlborough, Massachusetts, United States Michael Page Full time

Job Summary

Michael Page is seeking a Senior Chemical Engineer to lead the formulation development activities within the NPI Engineering team. As a key member of the team, you will be responsible for leading and optimizing chemical processes for the production of innovative medical equipment, ensuring the highest standards of quality, safety, and compliance with industry regulations.

About the Role

The Senior Chemical Engineer will report directly into the VP of Engineering & Technology and be responsible for:

  • Leading formulation development, coordinating project plans and execution.
  • Working directly with program management and engineering on the design, development, and qualification of new coating formulations.
  • Collaborating with cross-functional teams (R&D, Quality, Manufacturing) to develop innovative solutions and improve existing processes, materials, and technologies.
  • Ensuring that all chemical processes adhere to relevant FDA, ISO, and other regulatory standards, particularly for medical device manufacturing.
  • Overseeing process validation, risk assessments, and ensuring processes meet industry and company quality standards.
  • Leading and managing complex projects, including new product introductions, scale-up processes, and technology transfers, ensuring timely delivery within budget constraints.
  • Ensuring compliance with all safety, health, and environmental regulations in the plant, and leading initiatives to improve process safety and sustainability.

Requirements

  • Bachelor's Degree in Chemical Engineering.
  • 5+ years of experience in chemical engineering, preferably within medical device manufacturing or a related regulated industry (pharmaceutical, biotechnology).
  • Expertise in process engineering, including scaling up chemical processes from lab to full-scale production.
  • Strong knowledge of chemical properties, materials science, and medical device sterilization methods.
  • Experience with process validation, root cause analysis, and failure mode effects analysis (FMEA).
  • Proficiency in regulatory requirements for medical device manufacturing (ISO 13485, FDA 21 CFR Part 820, etc.).
  • Strong problem-solving skills, project management experience, and excellent communication skills for cross-functional collaboration.
  • Knowledge of AutoCAD, SolidWorks, JMP, and ChemTrak preferred.

What We Offer

  • Competitive compensation.
  • Comprehensive benefits plan.
  • Career growth opportunities.
  • Access to high-level management.
  • 401K match.
  • Excellent work-life balance.

Michael Page is an equal opportunities employer and welcomes applications from diverse candidates.



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