Sr Mechanical Engineer NIRSense Inc. Morrisville, NC Job Details Full-time 1 day ago Qualifications Rapid prototyping Regulatory compliance CAD design (engineering design task) Optics Design engineering Prototype creation Medical device design Product design Engineering product development Design for manufacturability (DFM) Design controls Biomedical regulatory compliance Subassembly Legal compliance Prototypes Mechanical knowledge Mechanical product development projects Full Job Description We are not working with any third-party vendors or on a C2C basis.

Please note:

This position is on-site in Morrisville, NC. This role can not be remote. About the

Company:

NIRSense is a world-leading non-invasive patient monitor developer. Our tools measure oxygenation changes in the body 10x deeper than typical pulse oximetry and track the electrophysiological activity of muscles and the brain. We are particularly focused on new to the world sensors that can be used and applied in rugged environments. We are a growing team of technology developers and we are seeking candidates interested in helping advance our capabilities for a wide range of interested stakeholders who are driven to transform the way humans understand and interact with their own health.

Job Summary:

NIRSense is seeking an experienced mechanical engineer to work alongside our growing engineering and scientific team in its Morrisville, NC office. This person will lead a broad set of development objectives for NIRSense's many customers. This person will integrate with a team of mechanical engineers, will manage project requirements for NIRSense systems and their mechanical designs, and will track open issues with NIRSense hardware designs. The ideal candidate is an experienced professional looking to apply their skills toward optimizing system and app interoperability for NIRSense's transformational capabilities. They work well in a fast-paced and high-performance team.

Minimum Qualifications:

B.S. or M.S. in Mechanical or Biomedical Engineering or a related field Eight or more years industry experience in design for wearable monitoring systems or medical devices Significant capability with Solidworks for designing rigid and/or flexible enclosures, molds, test fixtures, and optical interfaces Strong knowledge of safety, performance, and regulatory compliance requirements of medical devices, such as

IEC 60601, ISO 10993, ISO 13485, ISO 14971, IEC

62366, and related FDA guidance Experience in scaling up prototypes toward production Experience with rapid prototyping processes, including creating fixtures, molds, and prototype subassemblies Familiarity with Design for Manufacturing (DFM), Design for Assembly (DFA), and Design for Test (DFT) practices

Preferred Qualifications:

Experience designing waterproof and corrosion-resistant products Design experience with systems interfacing with the human body