Description: PDS Tech is seeking a candidate for the Product Engineer 1 position located in Flanders, NJ. Project Engineer is responsible for the development and implementation of stand-alone manufacturing test equipment (“testers”) that assesses the performance of electro-mechanical assemblies prior to installation into medical instruments or distribution to the service organization for repairs. Project Engineer must coordinate the engineering efforts of mechanical and electrical designers, software designers and verification/validation engineers to bring testers from concept through delivery. Project Engineers will also serve as the lead technical project coordinator for the development of testers by third party supplier who develop testers on clients behalf. As a Project Engineer 1, initial assignments will consist of supporting more experienced project engineers and/or assignment of independent projects of lower complexity. Project Engineers will travel to other Siemens R&D and production locations as well as third party supplier sites as needed to ensure project success.
Project engineers must solicit input from R & D engineers, production staff, manufacturing engineers and field service engineers to ensure all stakeholder requirements are satisfied. Candidate must work in a highly-regulated environment and ensure all quality process and safety requirements are met in the development and implementation of the test devices.
Project Engineer must review mechanical and electrical designs through NX and Team Center to ensure the design package meet the design intent and documents adhere to the clients engineering standards. Project Engineer will assemble and trouble shoot instrument/tester hardware to isolate design issues and create root cause analysis studies
Project Engineer must drive consensus and document the Testing Mechanisms (Testers) design development by facilitating stakeholder review meetings and creating meeting agendas, meeting minutes, functional specifications and design review presentations.
Project Engineer must be able to learn and apply manufacturing test strategies to the development of testers and to work with production personnel and quality organizations to develop validation protocols (IQ, OQ, PQ), acquire approvals, and coordinate the execution of same in the production environment. Project Engineers will support production site training and technical support of implemented testers. Job Requirements: o BS in Mechanical Engineering o 1- 3 years of work experience o Basic 3D / 2D NX CAD skills - creating component models / engineering drawings supported by organizational skills o Candidates must be able to work independently in a fast paced new product development environment. o Strong organizational, communication and interpersonal skills are required. Candidate must be able to clearly communicate ideas both orally and through writing to explain design features or issues with all level engineers, designers and drafters, and leadership. o Candidates must possess ability to handle multiple tasks, take ownership and responsibility for projects and their corresponding development milestones, and clearly demonstrated desire and success in meeting committed timelines. o Ability to interface with cross functional groups to develop testing systems for medical device manufacturing o Ability to work collaboratively in team environment, manage work to project schedules, present status updates on assigned responsibilities in clear concise manner and support the overall project objectives o Ability to create testing device functional specifications and communicate specifications with designers, software developers, and verification engineers o Ability to apply good judgment in design decisions considering stakeholder needs, project budgets and timelines, and quality/compliance. o Ability to read and create testing schematic diagrams o Assemble documentation packages from design systems, communicate to suppliers and track the procurement of materials o Highly self-motivated, self-directed, team orientated, and exceptionally attentive to detail. Proactively resolves issues in a timely manner so that they do not affect project timelines. o Review Component, Assembly drawings and Bills of Material, and other design documents looking for design completeness, design quality, component commonality with other designs o Proficient in Microsoft Office applications (Word, Excel, PowerPoint) o 20% travel time; ability to rent and operate vehicle to travel between Siemens or supplier sites; Ability to independently travel domestically or internationally to visit Siemens or supplier sites o Ability to carry 25 lbs. of engineering components to/from work areas, vehicle, or desk. Ability to stand, kneel, sit or crouch to build, trouble-shoot, operate test equipment and instruments for extended periods of time. o Drug screen o Background check
Preferred Additional knowledge or skills in the following areas would increase consideration for applicant success in the position: o Knowledge and experience of software driven electromechanical devices (example stepper motors), controllers, fluidic systems, optic systems, transport mechanisms, data acquisition, measurement devices, power distribution systems. o SAP, NX, Team Center experience o Knowledge of testing strategies o Experience in developing and implementing design of test and assembly fixtures o Understanding of material selection for use in test fixture designs o Use, implementation, selection, and/or design of production test equipment o Knowledge and use of design control systems o Mechanical design good practices and techniques, GD&T o Experience with MS Project o Experience in manufacturing, FDA regulated and/or new product development environment o Understanding of manufacturing process validation o Familiarity with quality management tools (i.e. SPC) o Familiarity with mechanical inspection techniques o Experience in machining processes o Experience working with suppliers for procurement of materials