Lazurite designs MedTech devices. Its ArthroFree® System includes the first wireless camera with FDA clearance for arthroscopy and endoscopy. Free of cumbersome camera cables, ArthroFree enables surgeons to work with maximum dexterity, precision, and focus. Without camera-cable-related interruptions, surgeons are able to keep their eyes on the monitor—and on their patients’ well-being. Lazurite commenced commercialization (initial sales) of its first product ArthroFree in 2023.

Position Summary:

The Senior Mechanical Engineer will work in all research and development activities related to vision and display systems and medical lighting and illumination. Additional areas of expertise that are of interest include mechanical design, design plastic parts, DFM, design for assembly, machining, etc.

The Sr. Mechanical Engineer is responsible for product level mechanical design including plastic component design, machined component design, and PCB integration. These activities include thermal simulations, IP67 ratings, surface testing, drop testing, etc.

This engineer must be able to work effectively in a small, nimble team – engaging external technical resources as needed using clear communication and strong interpersonal skills. Success in this role requires attention to detail, good experimental setup and tracking, the ability to work independently with excellent judgement, and a demonstrated track record of data-driven decisions.

Responsibilities:

• Mechanical Product Level design and Sub assembly design
• Design for thermal requirements, external touch temperature
• Design for IP67, water sealing
• Collaborate with the current engineering team to plan, architect, and implement future systems and new devices.
• Participate in design reviews for and new existing devices
• Responsible for supporting new product development via engineering analysis, simulation, preparation and testing of prototypes, and other duties.
• Understanding of the overall performance of products within the business and helping to identify potential areas of improvement
• Design and manufacturing of plastic parts
• Design and manufacturing of metal parts (Aluminum, others)
• Design for manufacturability
• Design for product assembly design
• Mechanical models
• Relationships with external suppliers
• Relationships with external design partners
• Documentation: design, component, testing, etc.

Principle Duties and Responsibilities:

The primary responsibility for of this team member will be to drive the development and launch of innovative surgical devices for peripheral nerves. This will include:

• Responsible for the design and development of advanced medical devices arthroscopy and endoscopy with the focus on mechanical engineering, including interest include mechanical design, design plastic parts, DFM, design for assembly, machining, etc.
• Responsible for supporting new product development via engineering analysis, simulation, preparation and testing of prototypes, and other duties. This will also require an understanding of the overall performance of products within the business and helping to identify potential areas of improvement.
• Manage design for reliability, regulatory compliance, manufacturability, testability, and cost for current and developed products.
• Creation of design control documentation including system requirements and functional analysis.
• Design, Analysis, and Testing of products and prototypes to demonstrate function and required regulatory compliance.
• Use project management skills to hit deadlines and meet project requirements.

Expected areas of expertise:

• Experience in the development of medical products; preferably in handheld, mobile and wireless devices

• Thermal analysis,

• Extensive experience creating ECOs for mechanical and component design
• Integration of electronic components and sub-assemblies
• Experience working with ODM/JDM partners and manufacturing suppliers
• Ability to work and communicate cross-functionally with minimal supervision
• A multitasking team player with project leadership experience

Tools:

• Design tools: Solid Works, Fusion 360 others a plus
• Prototyping tools: 3D printing, CNC tools

General:

• Working with a quality management system such as ISO 9001 or IEC13485 as well as IEC 62304.
• Work effectively in a small, nimble team – engaging external technical resources as needed using clear communication and strong interpersonal skills.
• Attention to detail and proficient in experimental setup and tracking.
• Ability to work independently with excellent judgement and a demonstrated track record of data-driven decisions.
• Standard computer skills (Microsoft Office, Outlook, Word, Excel, Visio).

• Understanding of medical device DHF, DMR, and DHR files management and documentation requirements, preferred.

• Broad knowledge of video and lighting technologies, preferred.

Education and Professional Requirements:

• Bachelor’s degree in mechanical engineering or related field. Master’s degree a plus.
• 6 or more years’ experience with new product development and system architecture
• Desire to work in a fast paced, small company environment as an integral part of a team.

Work Location:

• Warrensville Heights, Ohio

Benefits:

• Health insurance
• Dental insurance
• Vision Insurance
• 401(k)
• Health Savings Account
• Life insurance
• Paid time off
• Retirement plan