Manufacturing Engineer Mechanical

Horizons is looking for a Manufacturing Engineer (Mechanical) to join one of our clients Becton Dickinson (BD). You will be responsible for sitebased manufacturing activities associated with the implementation qualification and sustaining of a range of electromechanical products.

Location

• Hybrid (based in Oradea Romania): Home and Manufacturing Site
  

Key Responsibilities

• To work directly with contract manufacturers to implement processes into manufacturing ensuring that product specification quality and performance criteria are robustly met consistently within budget and to timescale commitments.
  
• To support the ongoing manufacture of highquality products and spares with respect to safety quality cost and delivery targets for first tier contract manufacturing and second tier suppliers.
  
• To implement production process improvements to support the company s continuous improvement targets.
  
• To act as a specialist for PCBA manufacture automatic and manual assembly and test electrical and electronic part manufacturing.
  
• To implement component design iterations to reduce cost and maintain/improve patient safety on BD products.
  
• Configuration management of engineering change documentation in accordance with BD Quality Management System requirements.
  
• Support reliability programmes with external suppliers.
  
• Process & Product verification and validation execution.
  
• Crossfunctional engagement with other functions as apart of ensuring compliant execution to QMS.
  
• Occasional lifting and carrying up to 15 kg.
  
• Occasional travel internationally.
  

Requirements

• HNC HND or Degree in Mechanical Engineering or equivalent qualification.
  
• Minimum 2 (ideally 5) years experience in the post release design / engineering support of medium volume electromechanical product.
  
• Experience of electromechanical assembly and manufacturing processes including knowledge of manual and automated assembly machining plastic injection moulding die casting post processing and finishing processes.
  
• Experience with production line quality control techniques structured faultfinding and investigation tools.
  
• Experience of working with suppliers on value engineering and supplier transfer projects.
  
• Experience within a medical device or other highly regulated manufacturing industry.
  
• English language verbal and written including technical writing is essential
  
• Creation review and update manufacturing documentation e.g. manufacturing & test procedures Bills of Material Failure Modes and Effects Analysis jig fixture & test equipment documentation.
  
• Experience with setting up assembly processes assembly jigs and fixtures application of pokayoke principles and robust process design techniques.
  
• Validation & verification activities for new process engineering changes process and product ideally with Medical industry experience (knowledge of validation planning TMV IQ OQ PQ processes and appropriate quality systems (cGMP CFR820 ISO13485)).
  
• Good understanding of revision control and configuration management.
  
• Demonstrated aptitude for problemsolving using structured problemsolving techniques; ability to determine solutions and clearly communicate for all stakeholders.
  
• Knowledge of Geometric Dimensioning & Tolerancing (GD&T).
  
• Proven ability in working in cross functional project teams (including Kaizen events).
  
• Knowledge of Six Sigma Lean and Continuous Improvement philosophies and techniques (including DMAIC Ishikawa 5Y Statistical Process Control process capability gauge repeatability and reproducibility).
  
• Ability to create understand and execute from project plans ideally proficient in MS Project or Smartsheet.
  
• Resultsorientated and able to work both independently and within a team environment.
  
• Proactive and the ability to take initiative own challenges and drive to a satisfactory and timely solution.
  
• Excellent communication skills with the ability to communicate in a global environment and at all levels.
  
• Ability to challenge collaborate simplify and solve problems creatively.
  
• Embodies trust integrity and ethics inside and outside the Company; High personal accountability & integrity.
  
• Computer literacy with a good working knowledge of Microsoft Office and project planning tools.
  
• Adhere to policies and procedures with regulatory and quality management system awareness.
  

Benefits