Position Summary
We are seeking a Design Assurance Engineer II to join our team. The ideal candidate is a talented individual who is enthusiastic about learning while making a difference in the world. The DA Engineer will have the opportunity to contribute to a variety of Design Assurance core responsibilities, being the key QA team member on one or more product development projects, working collaboratively with the R&D teams from concept generation through manufacturing transfer, and contributing to risk management process throughout. The role also includes directing cross-functional complaint teams on investigations and root cause analysis to drive product improvement, assisting with complaint metrics and analysis, development of automated metrics system, and managing CAPAs, as required.
Primary Responsibilities
Education or Certification Requirements
Minimum of 3-5 years of experience in design assurance/engineering roles within the medical device industry.
Experience with risk management methodologies (e.g., FMEA, fault tree analysis) and risk management tools.
Solid computer skills essential, including Microsoft Office Suite, Adobe, Minitab, etc.
Comfortable with basic statistics and data analysis
Knowledge of FDA regulations and ISO 13485 standards for medical devices
Experience with project management is a plus
Other Essentials and Key Success Factors
This position offers a competitive salary in the range of $62,000 – $90,000 annually, along with a comprehensive benefits package. Actual compensation will be based on relevant experience, education, and market factors.
The description and requirements outlined above are general; additional requirements may apply.
In accordance with Massachusetts law, General Laws Chapter 149, Section 19B. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.