R&D Innovator

2 weeks ago


Brockton, Massachusetts, United States Vakulatech Full time
Job Overview

Vakulatech is seeking a highly skilled R&D Engineer to join our team. As a key member of our product development team, you will be responsible for driving innovation and delivering high-quality products to market.

Key Responsibilities
  • Develop and implement new methods and specifications for reprocessing of assigned devices, ensuring compliance with industry standards and regulations.
  • Conduct complex hands-on and simulated testing for design verification and test method developments, utilizing advanced tools and techniques.
  • Review, edit, and create all engineering documentation related to assigned projects, including technical reports, work instructions, and method and process validation.
  • Lead basic engineering operations and complex scientific evaluations on new products, technology concepts, and product development, applying advanced algebraic and geometric formulas and tool engineering data.
  • Inspect and test prototypes, tools, and fixtures after fabrication to ensure they meet specifications, and write verification and validation documentation as needed.
  • Perform reverse engineering to identify functional and performance requirements for reprocessed devices, and develop solutions to meet customer needs.
Qualifications
  • Previous experience in medical device development is preferred, with a strong understanding of industry regulations and standards.
  • Experience with 21 CFR part 820 and ISO 13485 requirements, as well as DOE, FMEA, GMP, GDP, and QSR.
  • Proficient in Microsoft Office and Microsoft Project, with strong technical writing skills and ability to work within an ISO structured quality system.
  • Excellent written and oral communication skills, with the ability to balance multiple priorities in a fast-paced environment.
  • Ability to function independently as well as within a team, with a consistent record of completing projects on time and accomplishing goals.
Education
  • Bachelor's degree in Biomedical, Mechanical, Electrical Engineering, or equivalent.
  • Minimum of 2 years of increasingly responsible new product engineering experience.


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