Senior Design Engineer
|Job Title:||Senior Design Engineer|
|Job Published:||about 2 years ago|
Our client, a medical device company in Cork are currently looking to recruit a Senior Design Engineer for their site.
Through close collaboration with Customers and Marketing, will deliver high quality and innovative products, technologies and procedural solutions that will enable our client to continue to work with our Customers to make healthcare better resulting in increased market share.
Designs, develops, refines and evaluates mechanical components assemblies or subsystems for mechanical and/or electro-mechanical medical devices and implants. Uses concurrent engineering and rapid prototyping techniques to reduce product time to market whilst adhering to project deadlines and product costs.
Plan and execute successful product development projects, occasionally leading and training team members on technical aspects of product commercialization.
? Close cooperation with end customers to understand and validate users' needs. Work closely with marketing, surgeons and OR staff to develop initial design inputs and refine prototypes and final product designs throughout the product development lifecycle with a focus on projects in new or changing procedural areas.
? Development of medical devices from concept to commercialisation.
? Work with internal and external design teams to invent and create smart, innovative solutions to healthcare problems and mechanical/electrical design challenges.
? Conducts research in problem areas of considerable scope and complexity.
? Evaluate and optimize concepts for mechanical function and manufacturability. Develop product designs and create prototypes from customer concepts and/or specs to test and validate ideas
? Determine and implement design approaches and parameters and conduct feasibility studies on new designs. Analyse equipment to establish operating data, conduct experimental tests and evaluate the results. Lead and/or participate in design review meetings.
? Lead and contribute significantly in efforts to identify, determine product requirements, generate production drawings for parts and assemblies and develop and manage full product design documentation.
? Select components and equipment based on analysis of specifications, reliability and regulatory requirements. Work with advanced quality engineers to develop component specific testing and inspection protocols.
? Communicate with process development and manufacturing engineering to resolve technical challenges and optimize design for manufacturability and efficiency. Will ensure designs are cost efficient, manufacturable and reliable.
? Liaison with supply chain personnel for the specification and sourcing of raw materials
? This position is accountable for achieving product performance and quality objectives, project planning and effective execution, as well as communicating project status and escalating issues when appropriate.
? Independently determines and develops approach to resolving end customers product related issues, through problem solving and troubleshooting product design, and product training.
? Bachelor?s Degree in Science /Engineering is required.
? Minimum of 3+ years? experience within Manufacturing role or equivalent in either Medical device or Pharmaceutical Industry.
? Validation experience is a distinct advantage
? High level of PC skills required. The successful candidate must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages. Knowledge of Computer System Validation including GAMP 5 and 21 CFR part 11 requirements desirable.
? Working Knowledge/experience of Risk Based Techniques i.e. FMEAs, FTAs etc.
? Excellent communication skills and attention to detail.
? Have a good understanding of statistical techniques, in particular statistical sampling plans, Process Capability, Gauge R&Rs.
? Have a good understanding of engineering and machine tool fundamentals.
? Lean Six Sigma training a distinct advantage.
? Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
? Must be willing to work as part of a multi-site team, be able to travel as part of the job? Ability to effectively work cross-functionally with Product Dev., Quality, etc.
For further information on this Senior Design Engineer role in Cork please contact Nicola O?Connell on 091730022 / email@example.com
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