Manufacturing Engineer (2nd Shift)

Responsibilities

• Process Optimization: Validate robust manufacturing processes for LSR molding.
• Drive revalidation activities for process/tool/equipment changes in production.
• Lead process improvement initiatives to enhance productivity, cycle time, and material utilization.
• Design experiments and analyze data to optimize process parameters, ensuring consistent product quality.
• Develop and implement control plans, process flow diagrams, and PFMEAs to mitigate risks.
• Project Management: Serve as the technical lead in root cause investigations and implementing countermeasures.
• Cook with coordination with vendors and suppliers for equipment selection, procurement, and commissioning.
• Provide regular updates to stakeholders, including management, on project status and milestones.

Qualifications and Experience

• Required: Bachelor’s degree in mechanical engineering, Plastics Engineering, Manufacturing Engineering, or a related field.
• Minimum 3+ years of experience in Manufacturing Engineering (Ideally with Injection Molding/LSR Manufacturing).
• Hands-on experience with Molding machines and robotic automation.
• Proven track record in leading and supporting engineering projects in highly collaborative environments.
• Strong knowledge of quality systems (ISO 13485, FDA regulations) and validation protocols.
• Proficient in CAD software (e.g., SolidWorks) and data analysis tools (e.g., Minitab, JMP).

Preferred Qualifications

• Master’s degree in engineering field.
• Familiarity with medical device manufacturing and associated regulatory requirements.
• Knowledge of process monitoring systems (e.g., RJG, Kistler).
• Six Sigma Green Belt or higher certification.
• Strong leadership and project management skills, with a PMP certification preferred.

Core Competencies

• Analytical problem-solving and decision-making skills.
• Excellent communication and interpersonal abilities.
• Detail-oriented with a strong commitment to quality and compliance.
• Ability to manage multiple priorities in a fast-paced, dynamic environment.
• Team player with a proactive approach to innovation and continuous improvement.