ABOUT THE ROLE
Reporting directly to the Mechanical Engineering Manager, this is an exciting opportunity to join a growing team and provide key support through delivery of technical expertise in development of new products targeting the urology field.
- Contribute to the development of new devices, from early stage product concepts to ready for clinical trial product, in line with Eakin’s development strategy, Quality system and Development Process.
- Contribute as a team member to allocated work-streams within development projects, to meet project targets and ensure end-product meets with customer expectations and operational needs.
- Provide input to and author technical reports and design documentation for internal and external users to review, ensuring that the content is accurate and informed.
- Adopt a continuous improvement approach by proactively seeking out development opportunities by learning and attending training courses to ensure that department has right skills to deliver business needs.
- Provide theoretical mechanical engineering and process knowledge as an input to activities and business decision making within speciality area.
Job Specific Accountabilities
- Provide leadership in the development of Urological medical devices, both class I and II
- Lead the technical analysis of mechanical systems, such as tolerance analysis, Finite Element Analysis, Failure Mode and Effects Analysis (FMEA) and Design for Manufacturing and Assembly (DFMA) assessments to ensure that the parts that will form a product can be reliably and repeatedly manufactured and assembled.
- Lead the development of Test programs for new devices.
- Guiding the selection of materials backed up by a sound understanding of how they are predicted to work in the field.
- Support the Development of new manufacturing Processes with appropriate theoretical tools and techniques.
- Required to make decisions within remit above and to escalate issues with significant risk/implication to relevant Technical Lead(s), Project Manager(s) or Engineer(s).
- Uses a range of standard and well-established methods to guide decisions and ultimately establish themselves as a thought leader within the company for mechanical decisions.
- Objectives will be regularly reviewed and set in line with company plans.
- To adhere to the company’s Equal Opportunities policy and Dignity at work policy in all activities and to actively promote equality of opportunity wherever possible
- To be responsible for your own health and safety and that of your colleagues, in accordance with the company’s’ Health and Safety policy
- To adhere to the company’s Quality policy and Environmental policy
- To undertake other duties as may be reasonably required
- Experience in developing Class II medical devices, ideally catheters
- Educated to Degree level in Mechanical Engineering or similar technical degree.
- Able to demonstrate expertise in the application of Engineering analysis to real world problems (FEA, FMEA, DFMA etc.)
- Able to demonstrate working knowledge of experimental diligence and the ability to collect, analyse and interpret data
- Minimum 3 Years’ experience in a similar role
- Have a ‘can do’ attitude and be able to work on their own initiative
- Be able to work in a multi-functional team and to build relationships with peers.
- Have an ability to manage own time and work in a fast-paced environment and on multiple projects at one time.
- Further Post Graduate qualifications such as a Masters degree.
- Experience in taking product all the way through to launch
- Experience of high-volume manufacturing techniques for mechanical devices
- Experience in specification of injection moulding processes
- Expert in 3D parametric CAD systems such as SolidWorks
KEY WORKING RELATIONSHIPS
- Working within the Development team to provide leadership in the development of medical devices.
- Working alongside the Test Engineer(s) to ensure test programmes are measuring the important parameters.
- Working alongside the Industrialisation Engineer(s) to support the realisation of new products in a volume manufacturing environment.
- Working alongside Manufacturing to ensure the impact of technical decisions are understood fully by manufacturing.
- Working alongside the Commercial team(s) to understand the commercial implications of technical decisions
- Quality - ensuring all documentation is of an appropriate and consistent standard. Leading the analysis of failed products to ensure root causes are identified and eliminated as part of our CAPA process.
- External Consultants and HCP
- Test houses
- Medical device users
Problem solving – Generates and promotes solutions. Sees clearly which is the best way forward. Able to make decisions and commitments within appropriate time frame.
Resilience – Can work under pressure, remains calm, thinks clearly and manages emotion under pressure. Addresses issues without being aggressive or controlling and can easily bounce back from setbacks. Is open to feedback and doesn’t dwell on past events.
Networking – Feels relaxed about relating to people and soon forges and builds relationships. Works well in an environment of mutual support and information sharing. Is not afraid to direct people or ask for help.
Team Working – Enjoys participating in group activities and likes to work in close proximity with other people. Is ready to collaborate with and support others and is willing to co-operate and compromise for the overall good.
Analytical – Enjoys analysing qualitative data but also considers quantitative and seeks to identify and explore they key elements in information before making commitments. Tends to like to use facts and figures when planning and reporting and is concerned about accuracy and detail
Information Gathering – Enjoys dealing with and refers to factual data. Likes to be well informed and drills down into details. Prefers to access wide range of information and opinion before making decisions and when solving problems.
Planning and Organising – Thinks things through well in advance and maps out future activities, taking the key stages and requirements into account. Likes to monitor to ensure that things are implemented and delivered effectively
Quality Orientation – Is precise, pays attention to details, checks things and ties up ‘loose ends’. Has a strong conscience about getting things right and seeks to ensure that decisions and solutions do not involve undue risk, adheres to policy and standards.
Interpersonal / Influencing – Deals with other in a convincing way that leads to gaining agreement without relying on hierarchy and shows sensitivity to working relationships. Doesn’t give up easily in the face of opinions that differ from their own. Influences others to reach conclusions and gain agreements.
Technical expert –full breadth of technical knowledge and can operate as a technical advisor, influencing others to achieve goals without relying on hierarchy. Keeps up to date on changes within their field and implements plans to ensure organisation is in a state of readiness. Participates in industry and professional associations