Product Development Engineer
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POST DATE 8/20/2020
END DATE 10/18/2020
JOB DESCRIPTIONProduct Development Engineer
Supports assigned customers to assure best in class design and quality for product and provides seamless communication between Company and customers.
* Design and develop class III implantable devices
* Ensure designs meet performance specifications, regulatory and manufacturing requirements
* Manage product development projects
* Prepare, track, and communicate project plans that specify project phases, tasks, task interdependencies, durations, resource assignments, and costs
* Use software to develop detailed 3D CAD models and drawings
* Interact with customers in a professional manner; proactively communicate with customers to ensure an ongoing two-way exchange of information
* Maintain Design History Files
* Assemble and/or evaluate prototype devices
* Prepare documentation release packages, including detailed drawings, bills of material, and/or procedures; approve Document Change Orders (DCOs) and obtain approvals from others as required
* Working with all internal groups, identify trends and process gaps and suggest and assist in the implementaion of corrective actions and process improvements
* Promptly respond to product issues, taking appropriate action within the Quality System and continually building strong rapport with customers and suppliers
* Collaborate with all departments to develop optimal work order routings and Device History Records
* Lead the generation of redlined documentation and review prior to sign off
* Lead and oversee the training of Assemblers/Technicians/Inspectors as needed
* Oversee the generation of process validations/qualification documentation (e.g. validation protocols, IQ/OQ/PQ) and lead the implementation of protocols and completion of reports
* Lead customer specific team meetings
* Perform other activies as directed
* BS degree in Engineering is preferred
* 3+ years of medical device product design and development experience is required, catheter experience desired
* Demonstrated ability to bring products from concept to market
* Ability to interact with client companies in a professional manner
* Familiarity with FDA, QSR, and ISO 13485 medical device regulations and standards
* Depth of knowledge in one or more clinical areas
* Depth of knowledge in one or more product areas
* Depth of knowledge in one or more technical areas (ie sterilization)
* Flexibility, persistence, passion, resourcefulness, a drive to succeed, and an entrepreneurial spirit
Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascent s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts.
If you are ready to propel your career to new heights read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.