Sr. Chemical Engineer - Medical Equipment - Marlborough, MA

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Job description

In this Senior Chemical Engineer role play a crucial role in leading the formulation development activities within the NPI Engineering 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.

Client Details

My client serves medical device companies around the world working with customers from concept to commercialization. With a focus on innovation, quality, and reliability, they strive to empower healthcare professionals with the tools they need to make a difference in patients' lives.

Description

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

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

Apply today for immediate consideration!

Profile

• Bachelors 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

Job Offer

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

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

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