Job Title: Manufacturing Reliability Engineer

Location: Round Lake, IL

Hire Type: Onsite, Long-Term Contract

Job Summary: The Manufacturing Reliability Engineer will be responsible for ensuring the reliability and continuous improvement of manufacturing processes within a medical device manufacturing environment. This role involves analyzing current processes, implementing changes to optimize efficiency, and maintaining compliance with regulatory standards. The Reliability Engineer will collaborate with various teams to drive data-based decisions, resolve process issues, and support overall operational excellence.

Job Duties:

• Develop and implement strategies to enhance the reliability and performance of manufacturing processes and equipment.
• Analyze existing production methods to identify inefficiencies and recommend improvements to optimize efficiency and reduce waste.
• Collaborate with cross-functional teams to implement process improvements and monitor their effectiveness.
• Maintain and update process documentation, including standard operating procedures (SOPs), work instructions, and process flow diagrams.
• Utilize statistical analysis and data-driven approaches to assess process performance and guide decision-making.
• Identify and resolve process-related issues through root cause analysis, ensuring corrective actions are implemented effectively.
• Stay informed of industry trends and advancements to promote innovation and maintain a competitive advantage.
• Ensure compliance with regulatory standards, including FDA, ISO, and GMP requirements, across all manufacturing processes.
• Participate in risk assessments and contribute to the development of risk mitigation strategies.
• Provide technical support and training to production teams to ensure consistent and efficient execution of manufacturing processes.
• Collaborate with suppliers and external partners to improve the reliability and quality of materials used in production.
• Communicate regularly with management on process performance, improvement initiatives, and potential risks.
• Lead process improvement projects and act as a subject matter expert in process reliability.
• Uphold the organization's commitment to safety and quality across all functions.
• Continuously seek opportunities to optimize processes and reduce costs without compromising product quality.

Qualifications:

• Bachelor's degree in Engineering or a related field.
• Minimum of 5 years of experience in a reliability engineering role within a regulated industry, preferably medical device or pharmaceutical manufacturing.
• Strong knowledge of process improvement methodologies, statistical analysis, and root cause analysis.
• Experience with regulatory standards such as FDA, ISO, and GMP.
• Excellent problem-solving and analytical skills, with a data-driven mindset.
• Proven ability to work collaboratively in cross-functional teams.
• Strong communication skills and ability to effectively report on process performance to management.
• Commitment to maintaining high safety and quality standards.