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Product Development Engineer

IT Minds LLC
Providence, RI Full Time
POSTED ON 5/18/2024
Product Development Engineer - Providence, Rhode Island (On-Site)

Job Description

Has a need Product Development contractor need 6 - 12 months - Functional/Design Control - Input/Output verification validation

from a documentation point of view, physical testing, simulation testing components, integrity testing. testing planning, design verification testing, commercially, writing test protocols, running test method validations, gauge R R.

Risk analysis, pFMEA, UFMEA, and DFMEA.

  • B.S or M.S in biomedical or mechanical engineering or another relevant discipline
  • Proven experience with medical device product development, authorship of Design History Files
  • A thorough understanding of c.G.x.P principles and practices, ISO 13485, ISO 14971, and 21C.F.R.820
  • A strong understanding of statistical principles
  • Familiarity with Risk Analyses, including d.F.M.E.A., u.F.M.E.A., and p.F.M.E.A.
  • Must demonstrate strong interpersonal and teamwork skills, and willingness to engage with internal stakeholders to obtain feedback/guidance.
  • Develops and optimizes test methods to support the design verification, validation and commercialization of new medical device products.
  • Authors engineering technical reports, work instructions or procedures
  • Leads test method validation (TMV) and design verification tests in support of regulatory submissions and commercialization of new products.
  • Interacts with external development partners to achieve design verification and validation deliverables.
  • Identifies and reports out of specification results, data, and atypical/unexpected events that occur during testing activities and supports associated investigations, impact assessments and Root Cause Analysis (RCA)

Thanks & Regards

Krishna | IT Minds LLC |

Phone: (949)534-3939 Ext 406 Direct: 949-200-7533| Email: krishna@itminds.net |

  • : 9070 Irvine Centre DR, Suite 220 | Irvine, CA 92618 |

44075 Pipeline Plaza, Suite 305 | Ashburn, VA 20147|

102, Manjeera Trinity Corporate, Kukatpally, Hyderabad 500072|

www.itminds.net

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