Design, development and integration of our next generation technology enhancements or novel product to meet customer and market demands in rapidly growing and evolving LAAC (Left Atrial Appendage Catheter) marketplace. Test Method development for characterization testing and Verification/Validation testing. Apply scientific and engineering principles to manage and support decision making around key technical issues for the overall system and technical workstreams. Prototyping and development of concept ideas, processes and tests Leverage internal/external partners as necessary to achieve project objectives. Provide clear communication to stakeholders and team members at key technical updates. Understand clinical use cases and user interface requirements to support design decisions. Work cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing on complex projects. Provide work direction to technicians, and other engineers. Document development and analysis by writing documents, reports, memos, change requests. Solve engineering problems by analyzing the situation and recommend solutions or alternative actions. In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance to all documented quality processes and procedures. Ability to work both independently and in a team setting Proficient in CAD design software, analytical tools and instruments, rapid prototyping tools and methods, hands-on concept development experience etc. BS degree or more from an accredited school in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Biomaterials Engineering or related field. 6+ years of R&D engineering experience with a Bachelor's degree OR 5+ years with Master's Degree. Ability to provide technical insights as it relates to product design and leadership. New product development experience in implants or cardiovascular products Experience in medical device Product Development Planning (PDP) lifecycle process environment Ability to draw conclusions and make recommendations based on technical inputs Experience being a self-starter with a hands-on approach Excellent problem-solving, organizational, communication, and collaboration skills. Experience interacting with physicians and customers on product design Experience with implantable medical devices Experience in exploratory/TDP product development or early feasibility studies Experience in preclinical, polymer synthesis and biomaterials Experience in managing and supporting technical trade-off decisions to optimize design, performance, usability, manufacturability, cost-efficiency and reliability. Strong written and verbal communication, judgment, decision-making, and critical thinking skills. Ability to exercise a solution focused and flexible mindset
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