Candela Corporation Sr. New Product Introduction Engineer in Marlborough, Massachusetts
Sr. New Product Introduction Engineer
Requisition Number 2617
Location US - Marlborough, MA
Candela is recognized globally for its innovative energy-based technologies that change lives. Our new brand embodies our continued commitment to innovating medical aesthetic treatment solutions based on solid science and effective outcomes. 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.
As 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. Acts 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. 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.
Essential Job Functions
Interface and coordinate with designers, engineers, program management, service, procurement and other functional teams within Candela
Key point of contact between Candela development team and Contract Manufacturer
Lead and facilitate NPI meetings with Purchasing, Planning, Operations and R&D to track progress and production issues
Ensure key NPI Engineering gate deliverables are completed per the Product Development Process (PDP)
Responsible for Design Transfer Plan, Design Transfer / Product Transfer Checklist and Design Transfer deliverables
Authors documentation to support production, for example, work instructions, test instructions, flow charts and procedures.
Responsible for reviews, eliciting feedback and change management of associated requirements/inputs for the respective documents
Develop fixtures and ensure equipment readiness for product launch
Ensure completeness of design package from development team
Work with Candela Supply Chain and Contract Manufacturer to ensure timely delivery of components for builds (e.g. beta, pilot, PQ and mass production)
Review requests for quotes against current manufacturing capability
Participate in the selection of suppliers and their processes
Lead beta, pilot builds by ensuring the Contract Manufacturer has all elements of current design package, including fixtures, tooling, and manufacturing documentation
Work closely with Contract Manufacturer to lead IQ, OQ, PQ for NPI projects and conduct Gage R&R, DOEs, ranging studies, when necessary
Provide input for dFX activities
Provide input to dFMEA, pFMEA, hazard and other risk documentation
Coordinate with the Lifecycle Engineering team during manufacturing process development, PQ, pilot, and ramp-up of manufacturing for the project change of responsibilities
Support Lifecycle Engineering and Transfer Team during production; responsible for change management to release new design package, as required
Evaluate existing designs and recommended alternative methods of manufacturing raw materials (i.e. sheet metal, molded plastic components, precision machined parts), to minimize cost while maintaining a high level of mechanical integrity.
Cost and TAKT time goals are met for newly designed products
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)
Responsible for packaging Process validation protocols and test reports
Responsible for shipping and distribution validation protocols and test reports
Ensure that all products/processes to be developed comply with GMPs, FDA, and other regulatory standards/guidelines as well as company SOPs.
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
Experience in mechanical design and electro-mechanical systems
Experience with SolidWorks desired
Familiarity with sheet metal fabrication, injection molding, precision machining and mechanical and opto-mechanical assembly processes.
Self-directed, organized and problem solving oriented
Strong interpersonal communication skills with an ability to build relationships and work collaboratively with cross functional teams
Ability to effectively communicate and coordinate activities
This job description is not all inclusive and is intended to capture a majority of the job functions. Special projects and other tasks may be required by management.
Candela Corporation is proud to be an Equal Employment Opportunity and Affirmative Action Employer and is committed to creating a diverse and inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.