I'm working with a leading manufacturer of Medical Device products, based in Orchard Park, NY and they are looking for a Senior Product Development Engineer to join their team. This is an international client that have flourished in recent years and hiring quite heavily at the moment to take the next steps in their expansion.
In this role you will develop and fabricate new medical device products in line with our customer requests. You will manage simple project and communicate schedules and project design elements directly with customers and drives multi-functional ideation.
Resolves complex problems, diagnoses causes of fault in medical devices, and identifies sources of variation. Masters design controls, invents or innovates medical devices, renders design input/output documentation, risk documentation, manufacturing process methods, and test protocols/reports.
Responsibilities
initiates or approves engineering drawings, layouts, changes orders and specifications.
schedules, conducts, or coordinates detailed phases of the engineering work in a part of a major project or total project of moderate scope.
all necessary paperwork and documentation for all projects undertaken.
evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making adaptations and modifications.
track, and communicate project plans that specify project phases, tasks, task interdependencies, durations, resource assignments, and costs.
tasks and schedules.
of a large scope focused project and a supporting member on smaller projects.
3D component solid models and assemblies and create 2D details of components and assemblies.
Qualifications
Bachelor's degree, Masters preferred.
Minimum 5 to 7 years of medical device product design and development experience or equivalent desired.
Proficiency with SolidWorks.
level of understanding of Geometric Dimensioning and Tolerancing (ASME Y14.5-2018).
to apply GD&T to 2D product details.
expertise, proportionate to experience, in one or more of the following disciplines: mechanical, biomedical, electrical, software, firmware, process, or manufacturing engineering.
and in-depth understanding of FDA, QSR, and ISO 13485 medical device regulations and standards.
knowledge in multiple clinical, product areas, manufacturing processes and technologies and technical areas.