Familiarity with sheet metal fabrication, injection molding, precision machining and mechanical and opto-mechanical assembly processes.Experience in mechanical design and electro-mechanical systems.Bachelor of Science Engineering in Mechanical, Electrical or other technical discipline with a minimum of 5 years experience in new product introduction and a manufacturing environment.Ensure that all products / processes to be developed comply with GMPs, FDA, and other regulatory standards / guidelines as well as company SOPs.Responsible for shipping and distribution validation protocols and test reports.Responsible for packaging Process validation protocols and test reports.Interface with Engineering and Operations to ensure products are in accordance with approved data (Drawings are detailed with Critical characterizes and PPAPs are completed for qualification).Cost and TAKT time goals are met for newly designed products.sheet metal, molded plastic components, precision machined parts), to minimize cost while maintaining a high level of mechanical integrity. Evaluate existing designs and recommended alternative methods of manufacturing raw materials (i.e.Support Lifecycle Engineering and Transfer Team during production responsible for change management to release new design package, as required.Coordinate with the Lifecycle Engineering team during manufacturing process development, PQ, pilot, and ramp-up of manufacturing for the project change of responsibilities.Provide input to dFMEA, pFMEA, hazard and other risk documentation.Work closely with Contract Manufacturer to lead IQ, OQ, PQ for NPI projects and conduct Gage R&R, DOEs, ranging studies, when necessary.Lead beta, pilot builds by ensuring the Contract Manufacturer has all elements of current design package, including fixtures, tooling, and manufacturing documentation.Participate in the selection of suppliers and their processes.Review requests for quotes against current manufacturing capability.Work with Candela Supply Chain and Contract Manufacturer to ensure timely delivery of components for builds (e.g.Ensure completeness of design package from development team.Develop fixtures and ensure equipment readiness for product launch.Responsible for reviews, eliciting feedback and change management of associated requirements / inputs for the respective documents.Authors documentation to support production, for example, work instructions, test instructions, flow charts and procedures.Responsible for Design Transfer Plan, Design Transfer / Product Transfer Checklist and Design Transfer deliverables.Ensure key NPI Engineering gate deliverables are completed per the Product Development Process (PDP).Lead and facilitate NPI meetings with Purchasing, Planning, Operations and R&D to track progress and production issues.Key point of contact between Candela development team and Contract Manufacturer.Interface and coordinate with designers, engineers, program management, service, procurement and other functional teams within Candela.In this role, the candidate is expected to help establish best practices, resolve technical challenges using a data-informed approach and have excellent communication and strong project management skills. We aspire to provide the highest levels of clinical, technical, and customer support and continue to build on the longstanding partnerships of trust we’ve established with physicians, their practices, and the patients they treat.Īs part of the R&D department, the candidate will be responsible for working with Contract Manufacturers on New Product Introduction projects through all phases of product development to ensure a successful and timely transfer into manufacturing and then commercialization.Īcts as a liaison between Contract Manufacturer and Global Candela Teams to facilitate coordination of project activities including builds, build readiness and product quality (alpha, beta, pilot), fixture and procedure development as well as process validation and dFX activities. Our new brand embodies our continued commitment to innovating medical aesthetic treatment solutions based on solid science and effective outcomes. This job offer is not available in your country.Ĭandela is recognized globally for its innovative energy-based technologies that change lives.

Candela corp purchasing dept