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Mechanical Engineer, Human Factors

Company: Bionica Labs
Location: Cary
Posted on: November 25, 2022

Job Description:

About the Company:

Bionica Labs is a medical technology company focused on creating world-leading wearable sensor systems to measure cerebral oxygenation. We're a small, dedicated team seeking candidates interested in thoroughly understanding problems, excited about designing devices with broad applicability, and ready to follow where the prototype process leads us. We're searching for a fellow enthusiast to play an integral role in expanding our engineering team and capabilities.

Job Summary:

We are seeking a mechanical engineer with experience in human factors engineering to fulfill a set of system development objectives. This position will help expand our wearable prototype design and manufacturing capabilities from individual prototype iterations to wearable systems manufactured at commercial scale.

Job Responsibilities:
* Lead the human factors design and support the mechanical design of compact, wearable systems that involve digital and analog circuits, microcontrollers, optics, communication components, and other electrical components

* Work with electrical engineers to integrate PCB components with flexible or rigid enclosure designs that conform to the human body

* Develop and integrate mitigations for human factors wearability constraints for all physical designs, including product casings, optical skin interfaces, elastomers, and adhesives for placement on flat or curved body surfaces

* Check manufactured parts for accuracy to design intent and engineering tolerances

* Vet domestic and international manufacturing sources for Bionica Labs systems with a focus on manufacturing for scale and commercialization

* Translate user needs and functional requirement documents into specific design implementations

* 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 Bionica Labs 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:
* B.S. or M.S. in Mechanical or Biomedical Engineering or a related field plus five (5) 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, and optical interfaces

* Direct experience designing customer touch points on small electronics, such as buttons, membrane switches, clasps, removable components, and related subsystems

* Strong knowledge of human factor/usability engineering, safety, performance, and regulatory compliance requirements of medical devices, such as IEC 62366, IEC 60601, ISO 10993, ISO 13485, and ISO 14971, and related FDA HF guidance

* Experience working with medical-grade, skin-contacting adhesives and silicones

* Experience in scaling up prototypes toward production, specifically with biosystems

* Familiarity with Design for Manufacturing (DFM) and Design for Test (DFT) practices

* (Preferred) Design experience with optical systems interfacing the human body

* (Preferred) Prior experience with medical devices, working with startups, and with a local network

* (Preferred) Experience developing and iterating on industrial design concepts for manufactured systems

Salary: Compensation package will be commensurate with the successful applicant's experience. Anticipated hiring range is $90,000-110,000.

Hours: Full time

Travel: 0-10%

Interested applicants please forward 1) Cover Letter, 2) Resume/CV, and 3) Three professional references to Careers

Job Type: Full-time

Pay: $90,000.00 - $110,000.00 per year

* Paid time off
* Monday to Friday

Ability to commute/relocate:
* Cary, NC 27518: Reliably commute or willing to relocate with an employer-provided relocation package (Required)

* Bachelor's (Preferred)

* medical-grade, skin-contacting adhesives and silicones: 1 year (Preferred)
* Solidworks: 5 years (Required)
* designing customer touch points on small electronics: 2 years (Preferred)
* knowledge of human factor/usability engineering and safety: 2 years (Preferred)
* scaling up prototypes toward production: 3 years (Preferred)

Work Location: One location%58047475%

Keywords: Bionica Labs, Cary , Mechanical Engineer, Human Factors, Other , Cary, North Carolina

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