Senior Design/Staff Engineer

Work Flexibility: Hybrid<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p><b>What you will do:</b></p><p><b>Technical Responsibilities: </b></p><ul><li><p>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.</p></li><li><p>Conduct or design advanced prototyping and testing. Analyze and correct complex product design issues using independent judgment.</p></li></ul><p><b>Business Responsibilities:</b></p><ul><li><p>Advance solutions by applying in-depth knowledge of customer needs, market and competitive offerings. Apply detailed knowledge of clinical procedures to author design inputs.</p></li><li><p>Support Voice of Customer sessions internally and with clinicians. Demonstrate developing financial acumen.</p></li></ul><p><b>Med Device Compliance:</b></p><ul><li><p>Be proficient with and mentor others in usage of industry standards, including design requirements and test strategies per applicable regulations.</p></li><li><p>Lead creation and refinement of engineering documentation, such as the Design History file. Follow and mentor others on R&amp;D procedures like design controls and risk management, per the Quality Management System.</p></li></ul><p><b>General Responsibilities: </b></p><ul><li><p>Work cooperatively with R&amp;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.</p></li><li><p>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.</p></li></ul><p>Collaborate with cross-functional teams to build partnership to achieve business objectives.</p><p></p><p><b>What You Need:</b></p><p><b>Required Skills: </b></p><ul><li><p>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&amp;T and CAE tools</p></li><li><p>Adept at applying knowledge of materials and manufacturing processes to product design. Ability to communicate moderate complexity plans and technical information to team members.</p></li><li><p>Design &amp; Development of Instruments, Implants &amp; cases &amp; trays as per the medical device design control. Design &amp; Development of medical devices packaging. New product development is a must.</p></li><li><p><b>Skills / Engineering tools: </b>5-9 years of work experience in Creo, SolidWorks. MS Project Tolerance stack up</p></li></ul><p><b><span>Certifications:</span></b></p><ul><li><p>GD&amp;T</p></li></ul><p><b>Minimum Qualifications (Required):</b><br />• Bachelor of Science in Engineering, Mechanical Engineering or BioMedical<br /><br /> </p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>Travel Percentage: 10%<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p></p><p></p><p></p><p></p>