Process Engineer (Health and Medical)

• Analyze new product specifications and translate them into manufacturing processes to achieve production rates, quality levels, and product reliability;
• Complete the design and development of cost-effective and reliable manufacturing processes;
• Utilize demonstrated strengths in medical component and device design to plan and achieve goals;
• Develop process parameters for secondary operations;
• Conduct data analysis and collaborate with Quality Engineering;
• Identify Operational Qualification (OQ) process parameters and Performance Qualification (PQ) settings;
• Develop and document standard operating procedures (SOP) and product-specific operating procedures (PSOP);
• Train manufacturing personnel on SOPs and PSOPs;
• Perform DOEs and participate in the development of control plans, Process Maps, and PFMEA documentation;
• Collaborate with internal cross-functional teams and external vendors, while using standard problem-solving tools (e.g., 8D, 5 Whys, Fishbone);
• Apply effective inter-departmental communication and escalation;
• Own tooling and processes from a manufacturability standpoint, and partner with the Quality department on investigation and corrective action for failed inspections, executing continuous improvement activities;
• Partner with management to establish and develop site-specific processes as required/requested;
• Lead engineering activities and support day-to-day operations in the manufacturing area/s;
• Participate in "Gemba" walks and stand-up meetings as required;
• Ensure all Environmental, Health, and Safety instructions are implemented and participate in risk reduction plans;
• Provide mentorship to others through experiences and education as opportunities arise.

• Excellent verbal and written Maltese and English.
• Understanding of manufacturing processes for medical components and devices, and lead major projects.
• Strong understanding of metrology principles and methods.
• Leadership/Supervisory experience, with decision-making authority/responsibility.

• Degree in Mechanical/Electrical Engineering - A master's Degree will be given preference.
• Ideally hold 3+ years of experience in Pharmaceutical / BioPharma or related manufacturing industry.
• Ability to use Statistical analysis Software.
• Proficient in Lean Manufacturing problem-solving tools (5 why, Fishbone, 8D, etc.)

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