Job Title:
* Senior Product Development Engineer
We are seeking a highly experienced Senior Product Development Engineer to join our team in Galway. As a key member of the product development team, you will be responsible for leading product development activities for customer projects, ensuring that customer requirements are defined and translated into product specifications.
Key Responsibilities:
* Lead product development activity for customer projects to ensure customer requirements are defined and resolved into solutions.
* Engineering development of user-focused product solutions optimized for manufacture.
* Lead concept development, engineering, design verification stages of new product developments.
* Deliver Mechanical Design solutions for early stage and end-stage product development.
* Risk assessment, risk management as per ISO 14971.
* Prototyping and testing concept designs and initial engineering builds.
* CAD development & tolerance stack-up analysis - SolidWorks 3D CAD proficient in complex assemblies, surface modeling - 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/Output format.
* Statistical analysis of product test data using Minitab or equivalent software.
* Design verification, including development of test protocols & conducting of testing as per ISO 13485 / customer requirements.
* Work with Design team to define & complete product validation and usability testing.
* Work with customers to complete Design & Technical 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.
Requirements:
* Minimum 5 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 organization 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.