Synecco

This job description sets out to define the job role of a Senior Product Development Engineer, but it is not wholly inclusive. The role should be carried out with consideration of the following:

Based in Galway
Reporting to the Head of Design
Responsible for supporting the wider business as needed.

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

Duties & 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:
o Concept development, Feasibility, Design Verification & Validation execution stages of new products or product enhancements
o Delivery of Mechanical Design solutions for early stage and end stage product development.
o Risk assessment, Risk Management as per ISO14971
o Prototyping and testing concept designs and initial engineering builds
o CAD development & tolerance stack up analysis - SolidWorks 3D CAD proficient in complex assemblies, surface modelling - 2d drawings
o Pilot production trials to assess concept feasibility & troubleshoot design risk.
o Development of Product Specification & Test Method Development and documentation of such in Product Input w/Output format.
o Design verification, including development of test protocols & conducting of testing as per ISO13485 & ideally ISO1055.
o Work with Design team to define & complete Product validation and usability testing
o Work with Quality team to complete Design Stage Gate reviews
o 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