Our client, an established medical device and manufacturing company in Galway are currently looking to recruit a Senior Product Development Engineer for their site.
- Manage product development projects, both internally and on behalf of clients (e.g. project planning, quote/budget, tracking, risk management, reporting, communications etc.) using the 13485 and FDA 21CFR 820.30 guidelines
- Continuously monitor project performance against resources, timing, budget, risk and results and report variance to contract.
- Prepare reports/documentation to communicate status and results internally and to customers.
- Set up project design review agenda and facilitate effective project reviews in accordance with ISO13485 / FDA 21 CFR 820.30.
- As part of the design team, the candidate will be expected to work closely with, and manage both internal and external specialists to progress projects through to completion.
- Management of customer communications.
- Maintain Dept. Processes in line with Industry best practice. Ensure documentation/drawing standards for equipment meet company standards.
- Initiate proposals for improvement based on customer feedback or based on the identification of opportunities for improvement via new trends/ technologies / processes.
- Comply with internal and external regulatory requirements by ensuring that documentation such as Product development, manufacturing process and test specifications / procedures are completed and are in compliance.
- Develop products in Solidworks from inception through to transfer to production.
- Complete dimensional 2d Quality control drawings for manufacturing.
- Perform kinematic and engineering mathematical calculations and analysis.
- Develop and manage Design Verification Test protocols and reports
- Complete process development activities such as tolerance development to ensure robust function and process capability.
- Develop validation protocols for tooling and assembly processes and review validation reports for compliance.
- Complete Risk Management as per ISO requirements
- Liaise with manufacturing function to ensure manufacturability of products.
- Complete form, fit, function assessment, tolerance and capability analysis on high cavitation moulded assemblies
- Analyse data and problem solve using six sigma tools
- Work within a multidisciplinary team on diverse projects
- Manage prototyping activity within the project
- Resolve design, testing and manufacturing issues as they arise.
- Direct, develop and coach your direct reports - cultivate a strong team ethos - support talent management for direct reports.
- Participate in PR and Sales support activity as required.
- Degree in relevant engineering discipline. Master's degree an advantage.
- Level 8 Degree in Engineering Discipline,
- 10 years (min 8) direct engineering experience in medical device or other highly regulated manufacturing environment. Product Development experience.
- Strong Project management skills are essential - managing complex projects from concept through to transfer to production.
- Track record of external customer management
- Proficient in Solidworks 3d and 2d - Ability to build complex assemblies.
- Catheter project experience is an advantage.
- Capability in kinematic maths and engineering maths is essential
- Capable of analysing designs via FEAs and simulations
- Excellent analytical and problem solving skills.
- Must have an excellent understanding of design for manufacturing of injection tools and assembly processes.
- Experience in design and development of plastic products for manufacture and assembly and of manufacturing processes, e.g. Injection Moulding, Extrusion, Bonding etc.
- Fluent in design/development processes and tools (six sigma training) Process development.
- Results driven and able to deliver.
- Demonstrates a strong commitment to achieving results in collaboration with key internal and external customers.
- Excellent oral communication and presentation skills (written, verbal and visuals) for all levels of the organisation and customer base
- Commercially aware, able to develop effective project, and operational plans.
- Proven people management skills an advantage.
- Ability to deal with and manage change. Demonstrate flexibility and ability to adapt to changing requirements.
- High energy with the adaptability and flexibility to deal with continuous change and innovation.
- A strong strategic orientation with good day-to-day tactical management and attention to detail.
- Effectively handle multiple priorities
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