Senior Manufacturing Engineer

6 days ago

Galway, Galway, Ireland beBee Careers Full time

Senior Manufacturing Engineer

We are seeking a highly skilled Senior Manufacturing Engineer to join our expanding engineering team. Reporting to the Operations Manager, this role will be integral to optimizing, supporting, and advancing manufacturing processes through the application of technical expertise and Lean principles.

This is an exciting time to join our organization as we transition from an R&D focused entity into a more operational one. The successful candidate will work on setting up new manufacturing lines as we bring these processes in-house.

Key Responsibilities:
  1. Process Development and Improvement: Collaborate with other engineers and production teams to develop and improve manufacturing processes.
  2. Manufacturing Systems and Strategies: Develop and implement manufacturing systems and strategies to achieve cost, quality, and time objectives.
  3. Lean Methodologies: Identify and ensure implementation of opportunities to optimize/improve manufacturing processes using Lean methodologies.
  4. Problem-Solving: Apply structured problem-solving techniques to process, material or equipment issues while offering manufacturing or quality ideas from experience.
  5. Operational Processes: Develop and maintain operational processes and procedures incorporating industry best practices and in compliance with appropriate regulatory requirements.
  6. Process Analysis: Perform process analysis and identify areas for improvement, recommending and implementing solutions to enhance productivity and efficiency.
  7. Experimental Design: Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports.
  8. Manufacturing and Compliance Issues: Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
  9. Training and Documentation: Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
  10. Tech Evaluation: Work with internal team members to explore new technologies, assessing in terms of performance, cost, and reliability.
Requirements:
  1. Education: Degree level 8 in Engineering or related discipline with 5 years + relevant experience – additional relevant qualifications may be advantageous.
  2. Certification: Green Belt certification is a distinct advantage.
  3. Experience: Experienced with medical device process and manufacturing development and project/program management, risk analysis, and problem-solving skills.
  4. Design Verification: Knowledge of design verification and process validations, particularly as it pertains to equipment and manufacturing processes.
  5. Team Player: Dynamic team player who can work effectively and proactively on cross-functional teams.
  6. Organizational Skills: Excellent organizational and interpersonal skills, a team player, proactive and likes to take ownership of tasks/projects.
  7. Lean Principles: Good understanding of lean principles and methodology (e.g., DMAIC, Kaizen, Value Stream Mapping).
  8. Regulatory Knowledge: Excellent understanding of ISO 13485 and FDA processes.
  9. Statistical Techniques: Experience with statistical techniques (DOE, Six Sigma).
  10. Engineering Software: Proficiency with engineering software (e.g., AutoCAD, SolidWorks).

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