Mechanical Engineer

Mechanical Engineer

Work Location: Hybrid (Remote + Baltimore, MD)
Job Type: Full Time

Compensation: Salary + Equity

JuneBrain Inc. is recruiting an innovative Mechanical Engineer with a passion for positively impacting patient lives. This individual will help develop an impactful OCT imaging device, including design, fabrication, and testing of the system in preparation for FDA submission. Benefits include telework, a flexible schedule, 401(k), and unlimited PTO.

JuneBrain is an early-stage startup company empowering eye care and neurology communities through early detection & remote monitoring of disease progression: www.JuneBrain.com.

Essential Duties and Responsibilities:

− Execute diverse engineering tasks related to the development of the medical device

− Design, rapid prototype/fabricate, and evaluate mechanical, electrical, and optical systems (with support from our Optical Engineering consultants)

− Produce engineering drawings that appropriately capture the design intent with the appropriate views, dimensions, and tolerancing (as well as notes for suppliers and revision control)

− Perform calculations and simulations to verify the system design meets the specifications

− Design and execute testing protocols against standards to validate the prototypes and developed systems, including device safety, accuracy, and repeatability

− Investigate, troubleshoot, and resolve device, subassembly, and component issues

− Coordinate and communicate with hardware vendors to solve problems encountered during the development and manufacturing of device components

− Work with the Product Manager and manufacturing teams to assess and integrate user feedback into the device design

− Support software developers as needed with hardware-software integration efforts

− Work with Regulatory Specialist and R&D Manager to ensure design control and develop regulatory documentation for all design, assembly, and testing activities

− Participate in R&D efforts, including working with the Clinical Research Coordinator help with the design and setup of usability studies and troubleshoot device issues during the studies

Required Skill Set:

− Bachelor’s degree in mechanical, electrical, systems, optical, or biomedical engineering (or related discipline)

− 3 years of experience in medical device development

− Working experience with SolidWorks and prototyping techniques (e.g., CNC machining and 3D printing)

The Following Skills are a Plus:

− Experience developing optical imaging systems (e.g., OCT) and/or working with fiber optics

− Experience with wearables

− Experience with Zemax and C/C++ programming

− Experience with medical device regulations and quality management systems (GMP and ISO 13485 training)

− Experience in industrial design

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Flexible schedule
• Paid time off

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Baltimore, MD 21201: Reliably commute or planning to relocate before starting work (Required)

Experience:

• engineering: 5 years (Preferred)
• medical device: 3 years (Preferred)

Work Location: Hybrid remote in Baltimore, MD 21201