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Biolinq (San Diego, CA) is seeking to hire a full-time Principal Mechanical Engineer to lead its mechanical design efforts. A competitive compensation package (salary + equity) is offered in conjunction with the opportunity to define product specifications and shape the direction of Biolinq’s biosensor devices. You will have the unique opportunity to work in an exciting startup environment and contribute to the course of product development, design, and implementation.
This is a dynamic role as part of a team of engineers and scientists developing a novel intradermal biosensor technology. It is a highly influential role straddling R&D and product design, using extensive knowledge of mechanical systems, rapid prototyping, and manufacturing. You will have the opportunity to define the direction of the company’s first product, from R&D, to clinical trials, to regulatory submission. You will have the opportunity to define the direction of the company’s first product and beyond through concept ideation, design, and use of rapid fabrication techniques to create functional prototypes. You will demonstrate your sound analytical skills in evaluating designs, considering manufacturing feasibility, functional and cost requirements, and design optimization trade-offs.
* Designing, fabricating, and testing functional mechanical assemblies and systems to support R&D and manufacturing * Transitioning viable prototype designs to pilot and volume manufacturing; use of DFM methods and tools * Developing specifications and test methods to experimentally validate design choices, optimize system performance * Initiating and leading discussions with suppliers, vendors, and external manufacturers * Implementing mechanical modeling tools to assess mechanical failure modes; conduct FMEA * Working closely w/ various functional teams to implement seamless device-level integration * Working closely w/ contract manufacturers to transition prototype designs to volume manufacturing * Defining specifications, generating documentation, and establishing traceability measures based on regulatory requirements established by FDA, ISO, and various notified bodies
* BS or MS Degree in Mechanical Engineering, Engineering Physics, Mechatronics or equivalent field * 5+ years’ experience in the development of Class II or III medical devices * Solid experience with quality systems, including design controls under 21 CFR 820.30, ISO 13485, and related documentation protocols for medical devices, including compiling design history files * Proficient with solid and surface modeling (i.e. SolidWorks, AutoCAD, Inventor), GD&T, and DFM * Experience with rapid prototyping techniques such as 3D printing, CNC milling, and laser-cutting * Experience with the design and integration of electrical components and PCB assemblies into mechanical systems including tolerance stacking analysis * General knowledge of manufacturing techniques that implement injection molding, tapes, adhesives, and foams * Able to manage multiple projects, lead a team of mechanical engineers, and communicate ideas clearly to the team * Ability to effectively interface with electrical, mechanical, and biomedical engineers and work in a fast-paced, multi-disciplinary environment
Biolinq is a startup that has developed a proprietary wearable biosensor platform that is capable of measuring blood level information, without the need to draw blood. We are developing products that are changing the way patients and consumers access information about their body, by making new levels of actionable information readily available. We are dedicated to the personal and professional growth of all our team members and strive to create a positive and creative work environment.