Seeking an experienced mechanical engineer to work alongside our growing engineering and scientific team in its NC office. This person will lead a broad set of development objectives. This person will lead a team of mechanical engineers, will manage project requirements for our systems and its mechanical designs, and will track open issues with the hardware designs. The ideal candidate is an experienced professional looking to apply their skills toward optimizing system and app interoperability for our transformational capabilities. They work well in a fast-paced and high-performance team.Lead prototyping of compact, wearable systems that involve electronic components, rigid-flex PCBs, batteries, RF protection, flexible and rigid system casings, optical windows, displays, buttons, ambient light shields, and biocompatible skin interfacing materialsWork with electrical engineers to integrate PCB components with flexible or rigid enclosure designs that conform to the human bodyCoordinate task management among mechanical team membersMentor junior and mid-level engineers and support hiring processes for the mechanical teamDesign system protections for water ingress to depths hundreds of feet underwater and corrosion protection from salt spray and seawaterIdentify and qualify domestic and international manufacturing sources for our systems with a focus on manufacturing for scale and commercializationCheck prototype and manufactured parts for accuracy to design intent and engineering tolerancesTranslate user needs and functional requirement documents into specific design implementationsDesign test fixtures, molds, manufacturing jigs, and related subsystems to build, test, and validate prototype systems using in-house 3D printed and molded componentsFollow best practices for design controls and quality management systems including version control, configuration management, secure and compliant data storage and handlingCoordinate prototyping recipes and practices between engineering team and external manufacturing, material supply, and engineering vendorsProvide support to customers on-site and remotely for stage-gated device test milestonesReport to the Director of Engineering
Minimum Qualifications:B.S. or M.S. in Mechanical or Biomedical Engineering or a related fieldEight or more years industry experience in design for wearable monitoring systems or medical devicesSignificant capability with Solidworks for designing rigid or flexible enclosures, molds, test fixtures, and optical interfacesStrong 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 guidanceExperience in scaling up prototypes toward productionExperience with rapid prototyping processes, including creating fixtures, molds, and prototype subassembliesFamiliarity with Design for Manufacturing (DFM), Assembly (DFA), and Test (DFT) practicesPreferred Qualifications:Experience designing waterproof and corrosion-resistant productsDesign experience with systems interfacing with the human bodyExperience working with medical-grade, skin-contacting adhesives, silicones, and foamsExperience with human factor / usability engineeringExperience developing and iterating on industrial design concepts for manufactured systemsPrior experience working with startups and with a local network