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Product Development Engineer

Boston/Westborough

DESCRIPTION:

The Product Development Engineer is part of a cross-functional engineering team driving the design, development, verification, and manufacturing transfer of novel interventional medical devices.  The individual reports to the Director of Product Development.

RESPONSIBILITIES:

  • Summary and refinement of product specifications
  • Brainstorming of innovative device design concepts
  • CAD design of device concepts
  • Prototyping and evaluation of design concepts
  • Engineering design analysis, including tolerance analysis
  • Development and maintenance of drawing packages
  • In-vitro test method development and fixture design/fabrication
  • In-vivo and in-vitro study protocol development, execution, reporting
  • Development of manufacturing processes and documentation
  • Creation and maintenance of design controls documentation
  • Generation of product risk analyses
  • Initiation of document change orders, purchase orders or other business processes in support of product development activities
  • Fostering of client relationships and provision of responsive service in a contract environment
  • Adherence to Quality Management System procedures/design controls

PREFERRED QUALIFICATIONS

Preferred Education: B.S. in Mechanical or Biomedical Engineering

Preferred Experience:

  • 0 to 4 years’ experience in product development in an engineering or manufacturing role
  • Proficiency with MS Office suite and SolidWorks
  • Familiarity with ISO 13485 and 21 CFR is preferred
  • Familiarity with design for manufacturability is preferred
  • Detail-oriented and comfortable working in a highly regulated environment
  • Excellent analytical skills and the ability to solve complex design issues
  • Strong communication and teamwork skills

If qualified, apply now. Job title and job location must be included in the application.

To apply for this job, email your details, the job title and job location to hr@resonetics.com

Limitations and Disclaimer: The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position. Requirements are representative of minimum levels of knowledge, skills and/or abilities. To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.