Process Engineer (Health and Medical)

  South of Malta

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:

  • 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.)

Job Reference: AI329

  • Primary job focus
  • Job type
    Full Time
  • Employment level
    Experienced (3 years +)
  • Work Location
    On Premises
  • Employer industry
  • Languages
    English, Maltese

Engineering Jobs in Malta involve the production, preparation, alteration and repair of structures. Jobs in engineering include civil engineering, electrical engineering, environmental, general, maintenance engineering, mechanic, mechanical engineering, mechatronics, quality assurance, quality control, R&D, structural engineering, technical, technician and telecoms roles.

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