Duties and Responsibilities: Assist in the development of new products from concept generation through commercialization using design and development systems in accordance with FDA and international regulations.

• Collaborate with interdisciplinary teams, including quality assurance, regulatory affairs, and manufacturing, to ensure smooth transition from product concept to production.
• Work with senior engineers on complex projects; independently lead projects of smaller scope.
• Interact with marketing department and customers (ie, physicians) to identify and document new product requirements according to user and clinical needs.
• Design, build and test functional prototypes to demonstrate proof of concept in bench testing and animal studies.
• Develop and perform design verification and validation activities. Generate test protocols and test reports.
• Manage activities with outside vendors that provide components, assemblies, manufacturing processes, testing, and other services.
• Assist in the preparation and review of technical documents, including design inputs, risk management documents, test protocols, and reports.
• Develop, qualify, and validate new manufacturing processes and/or test methods.
• Document product development processes and outcomes in accordance with internal procedures and U.S. and international regulatory requirements.
• Stay current with the latest developments in the clinical field and contribute innovative ideas for new products or improvements to existing products.

Qualifications

Education & Certifications:

Knowledge, Skills & Abilities:

• Able to communicate technical issues at all levels.
• Able to read, write and understand English.
• Strong problem-solving abilities and attention to detail. 
• Must have initiative.
• Able to make sound decisions weighing all aspects of the situation.
• Good organizational skills.
• Proficiency in 3D CAD software, such as SolidWorks or AutoCAD. 
• Experience with design controls and risk management within a regulated industry is a plus.
• Highly motivated to learn and share new technical advancements.
• Good time management skills.