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Randstad US Medical Device Catheter & Mechanical Development Principal Engineer in Cambridge, Massachusetts

Medical Device Catheter & Mechanical Development Principal Engineer

job details:

  • location:Cambridge, MA

  • salary:$140,000 - $155,000 per year

  • date posted:Thursday, November 11, 2021

  • experience:10 Years

  • job type:Permanent

  • industry:Professional, Scientific, and Technical Services

  • reference:38793

job description

Medical Device Catheter & Mechanical Development Principal Engineer

job summary:

Cambridge MA based Healthcare Optics Research Laboratory is currently seeking an experienced, Medical Device Catheter and Mechanical Development Principal Engineer, (Principal Engineer) to design and implement robotic catheters, from initial concept to commercialization, in collaboration with world's leading medical institutions. This position is full time and offers a hybrid work schedule requiring the employee to be in the office three days per week and an option to work from home two days per week .

location: Cambridge, Massachusetts

job type: Permanent

salary: $140,000 - 155,000 per year

work hours: 9 to 5

education: Bachelors

responsibilities:

  • Lead and manage robotic catheter developments including, identification of the requirements, functional catheter design, design for manufacturing and prototyping

  • Lead and manage robotic catheter teams throughout the catheter development cycle, including planning, defining requirements, catheter design, prototyping, evaluation, verification and risk management

  • Work closely with other core team leads to establish core competencies for catheter design and technology for HORL

  • Ensure complete documentation adhering to regulations, standards and industry best practices under Design Control

  • Deliver robotic catheter designs for the product that meet the defined Design Inputs and catheter requirement specifications

  • Work closely with Project Managers for planning and execution to meet project check points and milestones

  • Work effectively in cross-functional teams consisting of Research, Engineering, Operations, QA/RA, and Marketing

  • Work closely with development teams in remote locations by interfacing with them as technical lead

  • Provide documentation of inventions for patent applications; review alternative technology as it relates to the invention

  • Guide and mentor less experienced team members to foster growth

  • Report progress regularly to Upper Management

qualifications:

  • Bachelor's degree or higher in Engineering (Materials, Mechanical, Plastics, or Biomedical)

  • 10+ years of relevant experience in design of medical devices and product development in a FDA regulated industry; 5+ years in a catheter engineering leadership role

  • Demonstrated experience in new product design leadership and management including leading conceptual design efforts, making appropriate modifications throughout the design process

  • High level of proficiency with solid modeling/CAD (Solidworks preferred)

  • Thorough understanding and extensive application of design for manufacturing, manufacturing process of catheter and/or disposable devices

  • Extensive knowledge on materials such as polymer, metals, and ceramics

  • Extensive experience working with consultants, outside partners, contract manufacturer and suppliers

  • Excellent verbal and written communication skills with the ability to communicate clearly to others in different functions and at various levels

  • Experience of development of an endoscopic device a plus

  • Experience in risk management (Hazard analysis, DFMEA, PFMEA, etc) documentation creation a plus

skills: FDA, Biomedical Engineering, GMP (Good Manufacturing Practice), Mechanical Engineering, Medical Device Product Development, Process Engineering

For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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