Job Description:

We are seeking a dedicated and knowledgeable Process Owner to join our team in the medical device industry. The ideal candidate will be responsible for overseeing and optimizing manufacturing processes, ensuring compliance with regulatory standards, and driving continuous improvement initiatives. This role is crucial for maintaining product quality and operational efficiency within our production environment.

Key Responsibilities:

• Define, implement, and maintain manufacturing processes for medical devices, ensuring compliance with industry standards such as ISO 13485, FDA regulations, and other relevant guidelines.
• Lead on process design and optimization efforts to improve efficiency, reduce waste, and enhance product quality.
• Troubleshoot process-related issues and implement corrective actions to minimize downtime and improve efficiency.
• Collaborate with cross-functional teams, including R&D, quality assurance, and manufacturing, to ensure seamless integration of new products and processes into production.
• Conduct regular process audits and inspections to identify areas of improvement, ensuring adherence to established Standard Operating Procedures (SOPs).
• Drive root cause analysis and corrective actions for non-conformities, ensuring timely resolution of process-related issues.
• Develop and deliver training programs for operations staff on new and existing processes, ensuring competency in manufacturing practices.
• Ensure compliance with Good Manufacturing Practices (GMP), safety regulations, and company policies.
• Analyze process performance metrics, preparing reports and presentations for stakeholders to communicate progress and improvement opportunities.
• Stay up-to-date with advancements in medical device manufacturing technologies and industry trends, translating insights into actionable strategies.

Qualifications:

• Bachelor’s degree in Engineering, Biology, Biomedical Engineering, or a related field. Advanced degree preferred.
• Minimum of 5 years of experience in process management or engineering within the medical device or related industry.
• Strong knowledge of manufacturing processes, quality systems, and regulatory requirements in the medical device sector.
• Proven experience with process optimization methodologies, such as Lean Six Sigma or other continuous improvement frameworks.
• Strong analytical skills with the ability to interpret data and drive decision-making based on insights.
• Excellent communication, leadership, and interpersonal skills to effectively collaborate with cross-functional teams.

Preferred Qualifications:

• Experience with project management and cross-functional team leadership.
• Knowledge of risk management and validation processes associated with medical devices.
• Familiarity with statistical process control (SPC) and other quality control techniques.

What We Offer:

• A competitive salary and comprehensive benefits package.
• Opportunities for professional development and career advancement in a dynamic industry.
• A collaborative and innovative work environment that values quality and continuous improvement.

If you are a results-driven professional with a passion for process optimization in the medical device industry, we invite you to apply for the Process Owner position!