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