Work Flexibility: Hybrid
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
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 or BioMedical & 4+ 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
Travel Percentage: 30%