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 Verification/Validation 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, RA/QA, product managers, project manager, and sales.

Duties/Essential Job Functions:

• Development of new products following established design control procedures from feasibility through product commercialization
• Create, maintain, and review documentation necessary for a Design History File (DHF)/Medical Device File (MDF), including Design Validation Plans/Reports, Test Protocols/Reports, User Needs, Design Input/Output Matrix, Risk Assessments, and Design Transfer in accordance with TSI QMS Procedures
• Perform hazard and risk analysis for new products, including dFMEAs, pFMEAs, and uFMEAs
• Identify all tasks required to complete project assignments according to Design Control procedures
• Work with both marketing and engineering to generate and/or contribute to the creation of prototype models to evaluate new design concepts
• Develop, revise, and/or review detailed engineering drawings
• Research and understand device functionality and intended clinical use
• Identify user needs and translate them into product specifications
• Establish design goals and specifications based on requirements and user needs
• Conduct or participate in brainstorming and root cause analysis
• Attend cadaver labs
• Provide technical review of regulatory submissions
• Participate in design reviews
• Review 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 audits
• Perform investigations for issues affecting product quality pre-launch

Experience/Skills:

• Good task and time management skills with the ability to work on multiple development projects simultaneously
• Full working knowledge of and experience with new product development in the medical device industry
• Excellent 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 Sales
• Strong technical writing skills
• Prior design experience using SolidWorks. Working knowledge of drafting standards and geometric dimensioning and tolerancing
• Experience 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 reports
• Ability to process customer complaints, engineering changes, and nonconforming product
• Demonstrated good written and verbal communication skills including presentation skills
• Assure preproduction quality requirements are met
• Creating detailed, comprehensive and well-structured test plans and test cases
• Estimating, prioritizing, planning and coordinating quality testing activities
• Proficient in Microsoft Office Suite

Required Education/Licensing/Certification:

• 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, and/or 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 / hybrid
• Occasionally may require travel (up to 10%)
• Occasionally requires attending corporate functions
• Business casual attire
• Lift up to 25lbs