Job details
What you will do:
Technical Responsibilities:
• Independently research, design, develop, modify, and verify components, modules and sub-systems for medical devices Translate user needs to design inputs/ specifications and produce complex system level designs with some guidance
• Conduct or design advanced prototyping and testing. Analyze and correct complex product design issues using independent judgment
• Working on multiple projects simultaneously in product engineering such as gap assessments, design changes, manufacturing transfers, product development, regulatory or business-driven projects, etc.
• Execution of NC CAPA implement design controls & risk controls.Experience in executing NPD projects involving the complete product development life cycle phases from concept to launch.
Business Responsibilities:
• Advance solutions by applying in-depth knowledge of customer needs, market and competitive offerings
• Apply detailed knowledge of clinical procedures to author design inputs
• Support Voice of Customer sessions internally and with clinicians. Demonstrate developing financial acumen
Med Device Compliance:
• Be proficient with and mentor others in usage of industry standards, including design requirements and test strategies per applicable regulations
• Lead creation and refinement of engineering documentation, such as the Design History file. Follow and mentor others on R&D procedures like design controls and risk management, per the Quality Management System
General Responsibilities:
• Work cooperatively with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success
• Identify and support the creation of or improvements to procedures, policies, processes, systems, and technology. Support and execute segments of complex multifunctional teams to advance projects through the design /development/launch process
• Deliver high quality results with passion, energy and drive to meet business priorities. Collaborate with cross-functional teams to build partnership to achieve business objectives
Minimum Qualifications (Required):
• Bachelor of Science in Engineering, Mechanical Engineering & 6-9 years of work experience
Preferred Qualifications (Strongly desired):
Technical Skills:
• Strong technical ability to develop and optimize designs for mechanical / electro-mechanical assemblies incorporating DFM principles
• Strong technical ability in creating engineering drawings, models, applying GD&T and CAE tool
• Adept at applying knowledge of materials and manufacturing processes to product design
• Ability to communicate moderate complexity plans and technical information to team members
• Good working knowledge of CAD applications (Creo/SolidWorks/UniGraphics)
• Experience with analysis tools, specifically tolerance analysis, CFD and FEA using ANSYS software preferred. Competency in statistics, process capability, design of experiments, including statistical applications such as Minitab, etc.
• Experience in working with regulated industries like Medical devices, Aerospace, Automotive etc. Understanding of medical device standards and regulations is preferred. Good understanding of designing of jigs & fixtures and inspection methods.
