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- 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.
Skill-sets and Requirements - 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.Education & Experience
- 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.)
Process Engineer - Malta - Konnekt
Description
Our client, an established manufacturing company, is looking to recruit a Process Engineer within the Health and Medical side of the business. Reporting to the Operations Manager, the chosen candidate will be responsible to: