Sr. Mechanical Engineer

Position Summary.

The Sr. Mechanical Engineer at Nuclein will play a pivotal role in the design, development, support, and validation of mechanical systems for Nuclein’s technologies. The individual will be responsible for leading the mechanical design process, ensuring compliance with regulatory standards, and collaborating cross-functionally to integrate mechanical components seamlessly into the technology and systems.

Essential Duties and Responsibilities. 

·         Lead the design and architecture of mechanical components, assemblies, and interfaces for Nuclein's medical devices.

·         Ensure designs meet specifications, performance targets, and regulatory requirements.

·         Design and prototype intricate mechanical components using CAD tools, ensuring precision and adherence to design standards.

·         Collaborate with cross-disciplinary teams to integrate mechanical components with electronic systems.

·         Operate within an FDA-regulated environment, ensuring all mechanical design activities adhere to relevant regulations and standards.

·         Contribute to the preparation of documentation for regulatory submissions related to mechanical systems.

·         Participate in the validation and verification processes, ensuring mechanical systems meet FDA and safety agency requirements.

·         Lead and participate in investigations related to on-market products, identifying root causes of mechanical issues and implementing effective resolutions in compliance with regulatory requirements.

·         Conduct thorough testing and validation of mechanical systems, identifying and resolving issues to ensure product reliability and safety.

·         Participate in the selection of key mechanical components and suppliers, considering factors such as quality, availability, and cost-effectiveness.

·         Drive continuous improvement in mechanical design processes, documentation, and testing methodologies to enhance efficiency and product quality.

·         Stay current with industry trends, emerging technologies, and regulatory standards relevant to mechanical systems in medical devices.

·         Support Operations and the deployment of manufacturing equipment

Education, Qualifications, and/or Experience. 

·         Bachelor's degree in Mechanical Engineering or a related field.

·         At least 5 years of proven experience in the design and development of complex mechanical systems, preferably within the medical device or diagnostic industry.

·         Proficiency in CAD tools (e.g., SolidWorks, AutoCAD) and familiarity with simulation tools.

·         Knowledge of regulatory compliance and standards in the medical device industry (ISO 13485, FDA regulations).

·         Strong problem-solving skills with the ability to troubleshoot and debug complex mechanical systems.

·         Effective communication and collaboration skills, with the ability to work in interdisciplinary teams.

·         Strong attention to detail and commitment to producing high-quality, reliable products.

•            Must successfully pass a background check and reference check.

Physical Requirements.  

·         Repetitive Motion: Mostly computer use

·         Weight Lifting: < 25 lbs

·         Position: Mostly sitting

·         Occasional use of PPE may be required in laboratory/manufacturing/warehouse areas