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Senior Project Engineer, Biomechanics

Company: The Judge Group
Location: Mahwah
Posted on: April 10, 2021

Job Description:

Location: Mahwah, NJDescription: Our client is currently seeking a Senior Project Engineer, Biomechanics for a 9 month + contract.*Need someone with at least 3-5 years of experience.**Candidate must electromechanical testing experience with a medical device or aerospace background.**Description/Comment: The Senior Project Engineer, Biomechanics, leads product safety or/and verification/validation test campaigns for innovative new electromechanical medical devices. Apply knowledge of engineering, biology, and biomechanical principles to the design, development, and evaluation of electromechanical products as well as related instrumentation.Additional Job Details: The Senior Project Engineer, Biomechanics is responsible for the planning, execution, analysis and documentation of safety and effectiveness testing for implants and surgical instrumentation intended for use within Craniomaxillofacial application. Responsibilities include: --- Prepare specifications for product safety and performance testing with a high degree of complexity (i.e. creation of test plans and complex test protocols). Typical products include electromechanical equipment. --- Project planning of product safety and performance tests and test campaigns. --- Execute product safety and performance tests including documentation in test protocols/reports and approval thereof. --- Develop, validate, and implement custom electromechanical testers and new test methods, with a continuous focus on test method optimization and compliance to Medical Device Industry Regulations. --- Analyze and assess results gained utilizing adequate analytical and statistical means and methods according regulatory standards and guidelines. --- Analyze and calculate loads (forces and moments) acting in the human body as input to simulations and calculations of implant loading as well as for adequate layout mechanical test set-ups.--- Manage external test projects (i.e. sterilizations validations, cleaning validations, biocompatibility testing, electromagnetic testing).--- Communicate, discuss, and conclude test and analysis results in cooperation with R&D department, Manufacturing groups, Quality Assurance team, Regulatory Affairs team, and Marketing Department in order to properly understand device design requirements, specifications, and constraints. --- Prepare and create new guidelines (standard operating procedures). What distinguishes you: --- You have earned a Bachelor's or Master's Degree in Mechanics, Electromechanics, Biomechanics, or Biomedical Engineering. Additional knowledge or degrees in Electronics (Minor) is additionally preferred. --- You have a minimum of 3+ years of relevant experience in the medical device industry or equivalent, especially of mechanical/electrical components with regards to ISO 60601-1. --- You have experience in electromechanical test method development and validation in the medical device industry is preferred. --- You have experience with circuit layout and familiarity with the mode of operation. --- You demonstrated proficiency in technical writing as it pertains to engineering/testing, including knowledge of design controls and documentation publication in a quality system for a heavily-regulated industry. --- You have demonstrated proficiency in Statistics (utilizing Minitab) and utilizing statistics to justify test samples size, acceptance criteria, and conclusions draw from test data. --- You have demonstrated proficiency in designing, ordering components for, and building fixtures utilizing Creo or other equivalent CAD platforms. --- You have strong organizational, interpersonal, communication and influencing skills in order to effectively interact with a diverse, cross-functional internal and external stakeholders. --- You are capable of working as part of a multi-disciplined team in a dynamic and results motivated environment --- You have excellent presentation and written / verbal communication skills --- You have demonstrable ability to work autonomouslySkills/Roles: --- Test Bench Generation, Expert, 4 years, Preferred --- Test Bench Execution, Expert, 4 years, Preferred --- Remote Collaboration, Expert, 3 years, Preferred --- Engineer, Intermediate, 4 years, Preferred --- Control Flow, Intermediate, 3 years, Preferred --- Test Definition, Firmware, Expert, 4 years, Preferred --- Schematic, Intermediate, 3 years, Preferred --- Statistical Analysis, Expert, 4 years, Preferred --- Matlab, Intermediate, 3 years, PreferredContact: eronan@judge.comThis job and many more are available through The Judge Group. Find us on the web at www.judge.com

Keywords: The Judge Group, Paterson , Senior Project Engineer, Biomechanics, Engineering , Mahwah, New Jersey

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