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Senior Mechanical Engineer

Recruiting Engine (MLS)

Apex, NC

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JOB DETAILS
SKILLS
3D Printing, Adhesives, Best Practices, Biomedical Engineering, CMVC (Configuration Management Version Control), Customer Support/Service, DFT (Design for Test), Data Storage, Design Services, Electrical Components, Electrical Engineering, Engineering, FDA (Food and Drug Administration), Functional Requirements Document (FRD), Hardware Design, Human Factors, ISO (International Organization for Standardization), Industrial Design, Industrial Development, Information/Data Security (InfoSec), International Electro-Technical Commission (IEC), Interoperability, Manufacturing, Manufacturing Design, Manufacturing Systems, Materials Engineering, Mechanical Design, Mechanical Engineering, Medical Equipment, Mentoring, Printed Circuit Board (PCB), Product Design, Project/Program Management, Prototyping, Quality Management, Radio Frequency, Rapid Prototyping, Regulatory Compliance, Regulatory Requirements, Requirements Management, SolidWorks, Startup, System Validation, Team Lead/Manager, Technical Recruiting, Test Design, Test Fixtures, Testing, Usability Engineering, Waterproofing
LOCATION
Apex, NC
POSTED
12 days ago
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 materials Work with electrical engineers to integrate PCB components with flexible or rigid enclosure designs that conform to the human body Coordinate task management among mechanical team members Mentor junior and mid-level engineers and support hiring processes for the mechanical team Design system protections for water ingress to depths hundreds of feet underwater and corrosion protection from salt spray and seawater Identify and qualify domestic and international manufacturing sources for our systems with a focus on manufacturing for scale and commercialization Check prototype and manufactured parts for accuracy to design intent and engineering tolerances Translate user needs and functional requirement documents into specific design implementations Design test fixtures, molds, manufacturing jigs, and related subsystems to build, test, and validate prototype systems using in-house 3D printed and molded components Follow best practices for design controls and quality management systems including version control, configuration management, secure and compliant data storage and handling Coordinate prototyping recipes and practices between engineering team and external manufacturing, material supply, and engineering vendors Provide support to customers on-site and remotely for stage-gated device test milestones Report to the Director of Engineering

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 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), Assembly (DFA), and Test (DFT) practices Preferred Qualifications: Experience designing waterproof and corrosion-resistant products Design experience with systems interfacing with the human body Experience working with medical-grade, skin-contacting adhesives, silicones, and foams Experience with human factor / usability engineering Experience developing and iterating on industrial design concepts for manufactured systems Prior experience working with startups and with a local network

About the Company

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Recruiting Engine (MLS)