Job Description:

Company Description: TeDan Surgical Innovations (TSI) designs and manufactures specialty surgical products for use in orthopedic, neuro, thoracic and spine surgeries. TSI was founded in 2006 with the goal to innovate and address evolving retraction techniques in spine surgery. We have successfully addressed the need for minimally invasive, posterior, lateral and anterior surgical approaches to the spine, and have introduced access instrumentation for neurological, orthopedic and cardiothoracic procedures. We commit to providing innovative, high-quality surgical access systems designed to optimize exposure and improve the surgeon experience.Job Summary: The Research & Development Engineer is responsible for the design and development of new products and the evolution of existing products. Primary areas of responsibility include Design Feasibility Activities, Design Control and Risk Management Activities, Design VerificationValidation Activities, Bench Testing, and constructing Design History Files and Risk Management Files in accordance with Quality System Documents. The R&D Engineer should have great attention to detail, as they will be involved with key tasks related to TSI's product quality and safety. The R&D Engineer works with a cross-functional project team consisting of design engineers, quality engineers, RAQA, product managers, project manager, and sales.DutiesEssential Job Functions: Development of new products following established design control procedures from feasibility through product commercializationCreate, maintain, and review documentation necessary for a Design History File (DHF)Medical Device File (MDF), including Design Validation PlansReports, Test ProtocolsReports, User Needs, Design InputOutput Matrix, Risk Assessments, and Design Transfer in accordance with TSI QMS ProceduresPerform hazard and risk analysis for new products, including dFMEAs, pFMEAs, and uFMEAsIdentify all tasks required to complete project assignments according to Design Control proceduresWork with both marketing and engineering to generate andor contribute to the creation of prototype models to evaluate new design conceptsDevelop, revise, andor review detailed engineering drawingsResearch and understand device functionality and intended clinical useIdentify user needs and translate them into product specificationsEstablish design goals and specifications based on requirements and user needsConduct or participate in brainstorming and root cause analysisAttend cadaver labsProvide technical review of regulatory submissionsParticipate in design reviewsReview manufacturing process for manufacturability, quality requirements, design requirements, and state-of-the-art validations (IQ, OQ, PQ)Provide support of DHF reviews during internal, external, and customer auditsPerform investigations for issues affecting product quality pre-launchExperienceSkills: Good task and time management skills with the ability to work on multiple development projects simultaneouslyFull working knowledge of and experience with new product development in the medical device industryExcellent communication skills in order to interface with internal and external cross functional team members including Manufacturing, Engineering, Regulatory, Quality, Product Management, Project Management, Marketing, and SalesStrong technical writing skillsPrior design experience using SolidWorks. Working knowledge of drafting standards and geometric dimensioning and tolerancingExperience with Medical Device industry standards preferred, such as reprocessing validation, packaging validation, human factors, risk management, etc.Strong working knowledge of Design Control, Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP)Experience executing verification and validation testing, and documenting test procedures and reportsAbility to process customer complaints, engineering changes, and nonconforming productDemonstrated good written and verbal communication skills including presentation skillsAssure preproduction quality requirements are metCreating detailed, comprehensive and well-structured test plans and test casesEstimating, prioritizing, planning and coordinating quality testing activitiesProficient in Microsoft Office SuiteRequired EducationLicensingCertification: Minimum 3 years engineering experience in the medical device industry, with a minimum of 2 years' experience in medical device product R&D.Technical writing, research paper writing, andor experimental design experience.Minimum Bachelor of Science (B.S.) degree from an ABET accredited school (or global equivalent) in one of the following engineering disciplines: Mechanical or Biomedical Engineering or a related subject.Physical Requirements: On-site hybridOccasionally may require travel (up to 10%)Occasionally requires attending corporate functionsBusiness casual attireLift up to 25lbs