Product Development Engineer
5 days ago
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.
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