Senior Research and Development Engineer
1 week ago
About Artech LLC
Artech LLC is a leading provider of innovative engineering solutions across diverse industries. We are committed to delivering high-quality products and services that meet the evolving needs of our clients.
Senior Research and Development EngineerWe are seeking a highly motivated and experienced Senior Research and Development Engineer to join our dynamic team. In this role, you will play a crucial part in designing, developing, and optimizing cutting-edge medical devices.
Responsibilities:- Design, develop, and refine transcatheter heart valve catheter delivery systems.
- Collaborate with physicians and researchers to conduct cadaver and animal studies, enhancing device usability and procedural effectiveness.
- Manage product interfaces across various components, including implants, catheters, accessories, and packaging. Ensure seamless integration and adherence to design specifications.
- Generate comprehensive work instructions, test methods, engineering models, and prototypes to characterize product performance and process requirements.
- Develop rigorous test strategies aligned with design objectives, execute protocols, analyze data, and prepare reports for regulatory submissions.
- Identify potential issues, conduct root cause analysis, and implement effective resolution strategies for parts, components, and sub-assemblies.
- Maintain and update design control documents, including risk analysis assessments, based on technical expertise and device functionality.
- Provide technical support during delivery system builds, addressing inquiries, conducting root cause analyses, and leading issue resolution efforts.
- Support clinical trials by providing physician/site training and offering case-specific assistance.
- Develop project plans to manage individual tasks and coordinate efforts across multiple team members.
- Contribute to shaping the direction of new products, processes, standards, or operational plans aligned with business objectives.
- Communicate effectively with internal and external stakeholders at various levels. Represent work through internal conferences and collaborations across diverse business units and functions.
- Bachelor's degree in a relevant technical field, preferably mechanical or biomedical engineering.
- Minimum of 4 years of experience in the biotechnology or medical device industry. Advanced degree with 2+ years of relevant experience may be considered.
- Proven problem-solving skills with expertise in root cause analysis.
- Hands-on experience in test method development, fixture design, and mechanical component design.
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