Mid-level industry position
Pos. Category: R&D
Pos. Type: Full Time
The Mechanical Design Engineer II, R&D is expected to be a key individual contributor of mechanical design expertise for R&D projects in a medical device company. The R&D Mechanical Design Engineer II applies a broad knowledge of engineering principals to design new products for ophthalmic surgery. He or she provides comprehensive product development services from conceptual design to product release. He or she approves modifications to existing designs, assesses acceptability of non-conforming parts, and troubleshoots product complaints in a team setting. The Mechanical Design Engineer II may also provide project coordination and leadership for select accessory development activities.
Leads assigned product development activities and performs comprehensive mechanical design-related tasks. Generates design concepts for new products based on marketing inputs. Collaborates with personnel from marketing, manufacturing, and quality to ensure that new designs meet customer requirements. Prepares documentation to ensure that product development processes comply with FDA accepted control guidelines. Creates 3D Solid Works/Inventor models and 2D prototype drawings for parts and assemblies. Assists R&D technicians in assembling new devices. Evaluates new prototypes against performance criteria and solicits feedback from marketing product managers. Attends surgical procedures and communicates with clinical advisors to acquire customer feedback for new products. Writes test protocols, performs experiments, and authors reports to support new product verification efforts. Participates in verification of new products and documents results. Reviews and approves design changes and verification plans for released products and procedural packs. Performs comprehensive engineering activities to support new product development, product improvement, and maintenance of business projects.
Scope of Position:
The Mechanical Design Engineer II 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.
Internal: Commercial, Operations, Design Quality, R&D Project Management, Regulatory Affairs
External: Surgeons/Key Opinion Leaders (KOLs), Nurses, Clinical Staff, Outside Technical Support Agencies
Required Education: BS in Mechanical Engineering
Ability to create electro-mechanical 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 knowledge of electro-mechanical systems, devices, and materials including pneumatic systems, fluidic management systems, and/or delivery systems. Broad knowledge of manufacturing methods. Expertise in mechanical design and tolerance analysis. Expertise with instrumentation and test equipment/software. Working knowledge of electrical systems and sensors. Good working knowledge of MS Office tools, analytical tools, project management tools, ERP systems. Excellent oral and written communication skills. Demonstrated ability to work cross-functionally.
Electro-mechanical, medical equipment design. Micro-mechanical component fabrication process selection/development. Computational Fluid Dynamic Analysis (CFD). Medical device design control and risk management expertise.
BS with Minimum of 3 years of experience involving medical device development and manufacturing in a GMP environment per ISO 13485 and CFR 821. Alternatively, 5 or more years of new product development experience involving mechanical/electro-mechanical devices.
5 or more years of product development experience involving design of electro-mechanical medical equipment or accessories. Experience with developing functional hardware designs using 3D software tools both individually and in collaboration with external industrial designers. History of applied technical 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. Demonstrated history of innovation demonstrated by patents and successful product introductions.