Senior Mechanical Engineer

Job Description Job ID# :

1075

Job Category : Contract or Direct

Contract or Direct

Duration : Temp-2-Direct

Temp-2-Direct

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

Job Requirements Minimum Security Clearance :

Confidential

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