The R&D Design Engineer II, Human Factors is expected to be a key individual contributor of design expertise for R&D projects in a medical device company where human factors engineering expertise is demanded. He or she applies a broad knowledge of mechanical and/or biomedical engineering principals in conjunction with specific human factors engineering skills to develop new products for ophthalmic surgery. He or she may provide comprehensive product development services from conceptual design to product release for individual accessories or elements of a surgical system where ergonomic considerations, usability, or other human factors are critical. He or she approves modifications to existing designs, assesses acceptability of non-conforming parts, and troubleshoots product complaints in a team setting. The R&D Design Engineer II may also provide project coordination and leadership for select accessory development activities or sub-projects.
Leads assigned product development activities and performs comprehensive accessory and/or hardware design and development tasks. Defines design input requirements driven by human factors and usability considerations as a member of a system development team. Generates/communicates design concepts, storyboards, etc., for new products and/or user interface elements of systems based on customer/commercial needs and inputs. Collaborates with cross functional personnel to ensure that new designs meet customer requirements. Prepares documentation to ensure that product development documents and records comply with FDA accepted control guidelines. Provides subject matter expertise to the usability engineering process and demonstration of conformity to usability engineering standards. Creates 3D models and 2D prototype drawings for parts and assemblies. Reviews and approves design drawings. Evaluates new designs against performance criteria. Attends surgical procedures and communicates with clinical advisors to acquire customer feedback for new products, especially with respect to ergonomics and usability. Writes test protocols, performs experiments, and authors reports. Executes verification and validation of new products and documents results for archive in the design history file. Reviews and approves design changes and test plans. Authors text to be included in the manuals and instructions for use. Performs comprehensive engineering activities to support new product development, product improvement, and maintenance of business projects.
The R&D Design Engineer II, Human Factors shall be an individual contributor and technical lead for development efforts involving the ophthalmic equipment and equipment accessories. The position involves both the individual contribution of organic hardware designs as well as collaboration with third party contract design service providers. As an individual with specific expertise in human factors engineering, he or she may serve as the subject matter expert when matters of usability, user/product interfaces, and associated requirements are in question, and may act as lead liaison with external design firms.
Required Education: BS in Biomedical Engineering or Mechanical Engineering
Formalized training and/or history of application of human factors engineering principals for new product development. Excellent oral and written communication skills with strong history of technical requirement, protocol, and report writing. Ability to interface with surgeons, nurses, and other end users to ascertain usability and human factors needs or assess fulfillment thereof. Ability to create designs using Solid Works, Autodesk Inventor, or equivalent software. Ability to interpret and create engineering drawings, specifications, reports, and other engineering or manufacturing documentation. Strong technical knowledge of electro-mechanical systems, devices, and materials including pneumatic systems, fluidic management systems, and/or delivery systems. Ability to apply engineering principals to select optimal materials, manufacturing processes, and suppliers for a device under development. Ability to use various instrumentation and test equipment/software to perform experiments or develop test methods. Good working knowledge of MS Office tools, analytical tools, project management tools, ERP systems. Demonstrated ability to work cross-functionally.
BS with Minimum of 3 years of experience involving medical device development and manufacturing in a cGMP environment per ISO 13485 and 21 CFR 820, with emphasis on usability engineering. Alternatively, 5 or more years of new product development experience with specialized expertise involving an equivalent, systematic process for creating quality user interface designs for non-medical products.
FDA CFR820 and ISO 13485 Medical device design control expertise. ISO 14971 risk management expertise. Training or history of application of usability engineering for medical devices per BS EN 62366. Micro-mechanical component fabrication process selection/development. Project management tools. Product life cycle management software expertise (ARAS Innovator). Cataract or Vitreoretinal surgery application knowledge or training.
5 or more years of product development experience involving design of electro-mechanical medical equipment and/or accessories with heavy focus on user interface aspects thereof. Experience with developing functional hardware designs using 3D software tools both individually and in collaboration with external industrial designers. History of applied core engineering expertise involving pneumatics, hydraulics, acoustics, ultrasonic energy, thermodynamics, lasers, or fiber optics. Design of products fabricated using diverse manufacturing processes such as milling, turning, EDM, laser welding/cutting, injection molding, ultrasonic welding, surface coatings, heat treatments, chemical treatments, tube forming, adhesive bonding, and automated assembly. Experience with Design for Six Sigma, QFD, and DFM tools. Experience in leading communications with external design partners to achieve successful development collaboration. Demonstrated history of innovation demonstrated by patents and successful product introductions. Successful development project leadership experience. Demonstrated commercial success for developed products. Technical publication or presentation examples.