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Product Development Engineer

2 months ago

Ilfracombe, Devon, United Kingdom Belcan Full time

Job Summary:

The successful candidate will be responsible for mechanical engineering and validating new tooling and processes, developing existing equipment, and writing robust validation documents for a leading provider of technologies and services in the therapeutics industry.

Key Responsibilities:

  • Develop and validate new tooling and processes to improve manufacturing efficiency and product quality.
  • Write and execute validation protocols (FAT, IQ, OQ, PQ) to ensure compliance with industry standards.
  • Provide progress reports and organize development and qualification batches to meet project deadlines.
  • Liaise with suppliers of materials and equipment to ensure timely delivery and quality.
  • Participate in focus team meetings and present manufacturing details to stakeholders.
  • Solve problems using Six Sigma tools, trend analysis, and process risk assessments to minimize downtime and optimize production.
  • Control and retain all Manufacturing Design Documents to ensure compliance and regulatory requirements.
  • Ensure compliance with Health & Safety practices to maintain a safe working environment.

Qualifications and Skills:

  • Formal Engineering Qualification (HNC/HND/Degree) with relevant mechanical tooling experience.
  • Knowledge of tool and equipment design, polymer welding technology, and process validation procedures.
  • Competent in Microsoft Office applications; knowledge of Minitab and SAP is an advantage.
  • Ability to read and interpret engineering drawings.
  • Strong interpersonal and communication skills.
  • Experience in machine and tooling design, and validation within the medical device or Bio-Pharmaceutical Manufacturing Industry.
  • Ability to work under pressure and meet deadlines.
  • Full UK driving licence and willingness to travel occasionally.