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

TeDan Surgical Innovations

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TeDan Surgical Innovations | Research And Development Engineer