
Senior Process Engineer
1 day ago
As a senior process engineer, you will be responsible for developing and optimizing manufacturing processes to ensure product quality, regulatory compliance, and operational efficiency.
Key Responsibilities:
- Lead the design and development of manufacturing processes for medical devices in compliance with FDA, ISO 13485, and GMP regulations.
- Drive process improvements to enhance product quality, reduce costs, and improve efficiency using Lean and Six Sigma methodologies.
- Support new product introduction by developing scalable and validated manufacturing processes from concept through commercialization.
- Collaborate with cross-functional teams to ensure seamless technology transfer.
- Investigate root causes, implement corrective actions, and ensure their effectiveness and sustainability.
- Develop and maintain process documentation, including work instructions, PFMEA, process flow diagrams, and control plans.
- Provide technical guidance to junior engineers and manufacturing teams.
- Select, install, qualify, and maintain equipment strategies.
- Ensure compliance with industry standards, safety regulations, and regulatory requirements across all processes.
- Lead cross-functional projects focusing on yield improvement, scrap reduction, and cycle time optimization.
- Bachelor's or Master's degree in Mechanical, Biomedical, Industrial, Chemical, or related Engineering field.
- 10+ years of proven process engineering experience in the medical device industry.
- Strong knowledge of ISO 13485, FDA 21 CFR Part 11/Part 820, and GMP requirements.
- Hands-on experience with process validation, equipment qualification, and test method validation.
- Expertise in Lean Manufacturing, Six Sigma, DOE, and statistical analysis tools.
- Proven track record in new product introduction, process scale-up, and technology transfer.
- Strong problem-solving skills with experience in root cause analysis and risk management.
- Excellent communication, leadership, and collaboration skills.
- Six Sigma Green/Black Belt certification.
- Experience with automated manufacturing systems, robotics, or advanced manufacturing technologies.
- Knowledge of polymer processing, assembly techniques, or packaging processes for medical devices.
- Familiarity with software tools such as Minitab, SolidWorks, or similar engineering applications.
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