You Will:

• Lead the development and maintenance of technical knowledge related to the technology and product development of airway access devices, endoscopic devices, and adjunct tools. 
• Develop and implement advanced mechanical concept designs, perform tolerance analysis, finite element analysis, and other design analyses. 
• Design components for manufacturing via plastic injection molding, stamping, machining, extrusion, and related processes, considering high-volume assembly processes in design concepts. 
• Ensure designs meet and exceed product specifications, regulatory requirements, and international standards. 
• Provide technical feasibility assessments and translate voice of customer (VOC) feedback into engineering design requirements. 
• Develop specifications, test methodologies, and test equipment to evaluate design concepts. 
• Perform calculations, analyses, and engineering testing to verify designs, documenting results in reports and laboratory notebooks. 
• Create and release engineering drawings and process engineering change orders. 
• Collaborate with suppliers to ensure components meet design requirements and diagnose design problems. 
• Develop and optimize manufacturing processes to ensure the scalable production of high-quality medical devices. 
• Implement Design for Manufacturability (DFM) and Design for Assembly (DFA) principles to enhance product reliability and reduce manufacturing costs. 
• Conduct process validation, including IQ, OQ, and PQ, to ensure manufacturing processes meet regulatory and quality standards. 
• Travel to vendor locations and customers, both globally and domestically, to help ensure program deadlines are met and troubleshoot issues. 
• Present technical findings and project status to cross-functional teams and management through design reviews, presentations, and other communication means. 
• Recommend various technology options or approaches for system, processes, facility, or program improvements in terms of safety, performance, efficiency, or costs. 
• Support the transfer between phases of the project life cycle. 
• Designs, develops, analyzes, troubleshoots and provides technical skills during research and/or product development.
• Designs studies to investigate specific life science questions within field of expertise.
• May be involved in product research and development and/or clinical trials.
• Translates research discoveries into usable and marketable products.

Must Have: Minimum Qualifications 

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Design and Industrial Engineering or a related technical field with 7+ years of engineering experience OR

• An advanced degree in in Mechanical Engineering, Biomedical Engineering, Design and Industrial Engineering or a related technical field with 5+ years of engineering experience

Nice to Have 

• Experience with 3D modeling software, preferably SolidWorks 
• Proficiency in Geometric Dimensioning and Tolerance (GD&T) practices 
• Strong understanding of mechanical engineering principles and methodologies 
• High degree of initiative and self-motivation 
• Expertise in Design for Manufacturability (DFM) and Design for Assembly (DFA) principles 
• Knowledge of process validation, including IQ, OQ, and PQ 
• Experience with advanced manufacturing technologies and processes, such as additive manufacturing, automation, and robotics 
• Familiarity with regulatory standards and quality systems in the medical device industry 
• Experience with rapid prototyping methods 
• Experience in the design and manufacture of medical devices 
• Familiarity with quality systems and regulatory standards 
• Experience in product design and development in an R&D environment, including surface modeling and mechanism design 
• Expertise in polymer material selection and optics 
• Ability to manage multiple tasks and projects effectively 
• Hands-on experience with measuring equipment and rapid learning capabilities for new equipment 
• Solid understanding of contemporary manufacturing techniques 
• Understanding of color, material, and finishing principles (CMF) 
• Strong interpersonal skills and effective problem-solving abilities 
• Experience solving ambiguous problems in a high-stakes environment 
• Experience designing and developing portable miniature electromechanical assemblies 
• Hands-on, handy with measuring equipment and/or able to learn how to use new equipment fast