Position Summary
Key Responsibilities:
Key responsibilities will include (but are not limited) to the following:
1. Develop and characterise device manufacturing processes for new commercial opportunities.
2. Take responsibility for new equipment purchasing, installation and commissioning.
3. Carry out validation work in accordance with the appropriate FDA and ISO regulatory requirements.
4. Work as part of project teams to develop new processes and deliver new products to the Manufacturing team.
5. Identify and implement improved processes which will eliminate waste and deliver a more efficient and effective commercial result.
6. Where possible, provide technical support on new technology and process development across the plant with an emphasis on supporting the development of robust manufacturing processes.
7. Become proficient in the relevant manufacturing processes so that the incumbent has a strong understanding of the factors which will have an effect on qualifying manufacturing processes.
8. Ensure full compliance with regulatory requirements.
9. Ensure Quality and EHS policies and procedures are adhered to at all times.
Professional skills/knowledge
1. Basic Project management skills.
2. Understanding of Teleflex Quality system.
3. Statistical analysis.
4. Structured Problem Solving techniques.
5. Understanding of Lean Principles.
6. Ability to drive projects to completion.
7. Technical report writing.
8. Process validations/FMEA's and protocols.
9. Understanding of Health & Safety - Machine safety, basic Ergonomics, electrical safety, Chemical safety.
10. Ability to generate and understanding technical drawing (AutoCAD/Inventor).
11. Understanding of new product introduction process.
12. Ability to influence employees that do not report directly.
13. An understanding of Validation and statistical techniques and an appreciation of their importance and use.
Education / Experience Requirements
1. A degree in Mechanical, Manufacturing, Biomedical or Polymer Engineering is essential.
2. Genuine Interest in Engineering and medical device development.
3. A strong technical aptitude and understanding of catheter manufacturing processes would be an advantage.
4. A self-starter, capable of working closely with operations in order to proactively support the overall goals of the company.
5. Ability to work under results related pressure to meet tight timelines and in hands on manner.
6. A person with strong mechanical skills who is willing to take ownership for the provision of engineering support in this role.
7. A person with strong communication skills.
8. Understanding and appreciation of Teleflex ethics Standards.
9. Thorough understanding of Teleflex processes and products.
Specialized Skills / Other Requirements
People
1. Clear verbal and written communication.
2. Ability to lead meetings.
3. Ability to work in a cross functional team.
4. Ability to use interpersonal skills to deal successfully with day to day people related issues.
5. Ability to influence employees that do not report directly.
6. Demonstrates behaviours in line with Teleflex Core Values.
Strategy
1. Understand the key drivers of our business.
2. Understand the role of engineering and its impact on the key business drivers.
3. Understanding of how other functions interact to achieve the company’s organisational goals.
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