Apply for this job now

Principal Engineer

Location
Boston, Massachusetts
Posted
3 Sep 2022

Due to tremendous growth, Indeio is looking for a Principal Validation Engineer to help continuously develop and enhance our portfolio of industry leading talent.


About us:

We are a spirited, high-growth company focused on the success of our clients and our colleagues. We put a new spin on consulting that allows our team to work at or with some of the world's largest and well-known medical device and pharmaceutical companies.


Responsibilities:

  1. Generation and execution of qualification/validation protocols including the generation, routing and approval of summary documentation.
  2. Must be able to read and understand engineering P&ID's and turnover documentation.
  3. Work with project teams to develop DOEs and statistically sound tests for appropriate support of results.
  4. Contribute to risk management activities including PFMEA generation.
  5. Complete test method validation, gauge r&r studies and other qualifications or studies to support product testing.
  6. Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.
  7. Change control, non-conformance and CAPA support.
  8. Participate in FDA inspections, ISO certifications, surveillance audits and customer audits.


Qualifications:

  • 2-5 years of experience in a Validation or Quality Assurance role for a medical device environment.
  • Bachelors Degree in Engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology, Chemistry).
  • Experience with qualifying medical device manufacturing equipment.
  • Candidate must possess sufficient knowledge and experience to serve as a subject matter expert within one area of validation.
  • Results oriented with a strong focus on quality principles.
  • Experience conducting validation studies and managing projects independently.
Apply for this job now

Details

  • Job Reference: 703137147-2
  • Date Posted: 3 September 2022
  • Recruiter: Indeio
  • Location: Boston, Massachusetts
  • Salary: On Application