Kelly Services are recruiting for a Galway based medical device company who are on the look out for a Senior Process Development Engineer.
Duties and responsibilities include but are not limited to:
- Lead & develop product development for customer projects (which may include multiple simultaneous projects) to ensure that customer requirements are defined, translated into product development specifications and ultimately delivered.
- Work closely with design and process development engineers to deliver user focused designs that are designed for manufacture when transferred to production.
- Lead and support the following product development activities:
- Concept development, Feasibility, Design Verification & Validation execution stages of new products or product enhancements
- Delivery of Mechanical Design solutions for early stage and end stage product development.
- Risk assessment, Risk Management as per ISO14971
- Prototyping and testing concept designs and initial engineering builds
- CAD development & tolerance stack up analysis - SolidWorks 3D CAD proficient in complex assemblies, surface modelling - 2d drawings
- Pilot production trials to assess concept feasibility & troubleshoot design risk.
- Development of Product Specification & Test Method Development and documentation of such in Product Input w/Output format.
- Design verification, including development of test protocols & conducting of testing as per ISO13485 & ideally ISO1055.
- Work with Design team to define & complete Product validation and usability testing
- Work with Quality team to complete Design Stage Gate reviews
- Work with Process Development team and Production teams to complete transfer to production and pre-production planning.
- Work with the PM to define, plan, track and report on Product Development projects; this should include use of Work Breakdown Structures, Project Plans, Costing etc.
- Lead development of project proposals outlining cost, schedule, risk etc. & liaise with customers to present and review proposals to secure project sale.
- Work with Customer complaints & Quality team to evaluate product non-conformances to assist in root cause analysis and recommend design modifications if appropriate.
Education and Experience required:
- Minimum 10 years' experience in product development for medical devices, ideally in highly regulated Class III devices
- Demonstrated understanding of various types of manufacturing, mechanisms, materials, tolerance-analysis and design-for-manufacturing is required.
- Mechanical Design experience required.
- Highly experienced in product specification design; translation of design inputs to engineering outputs, tolerance stack up analysis, as well as product testing; limit challenge testing, test method development, test method validation etc.
- Experience of working under medical device design controls, with proven knowledge of design verification/validation and design/process FMEAs is required. Experience of medical device regulations including GMP (Good Manufacturing Practices), QSR (Quality Systems Regulations) and ISO quality requirements is required.
- Experienced in Risk Management for medical devices and associated documentation processes.
- Excellent problem solving, decision making, and root cause analysis skills are required.
- Experience designing for manufacturability particularly for plastics, and experience with related supplier management;
- Highly experienced in project management, from conception to delivery; strong initiative and follow through in executing project responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experience is required.
- Excellent communication skills, both written and verbal; the ability to effectively communicate concepts, ideas and knowledge to all levels of the organisation is required.
- Experience in team management and a demonstrated track-record of being part of successful cross-functional product development teams is required.
- Proficiency in 3D CAD (e.g. Solidworks) and MS Office Suite is required
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.