Company Description
My client are a leading contract design and manufacturing partner to the medical device industry. Their mission is to enhance client capabilities and capacity in industrial design, user-centred design, advanced mechanical engineering, polymer process engineering and precision manufacturing.
Duties & Responsibilities:
Lead product development activity for customer projects (which may include multiple simultaneous projects) to ensure that customer requirements are defined, resolved into solutions and translated into product specifications for transfer to production.
Engineering development of user focused product solutions that are optimised for manufacture.
Lead (and for certain program support) the following product development activities:
Concept development, Engineering, Design Verification stages of new product developments.
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/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 ISO13485 / 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; this should include use of Work Breakdown Structures, Project Plans, Costing etc. (for smaller program the engineering lead may be the PM).
Lead development of project proposals outlining cost, schedule, risk etc. & liaise with customers to present and review proposals to secure project sale.
Work with Quality team to evaluate product non-conformances to assist in root cause analysis and recommend design modifications if appropriate.
Education & Experience Required :
Minimum 6 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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