Medical Device Design Control Specialist

5 days ago


Columbus, Ohio, United States MILLENNIUMSOFT Full time
Job Summary

MillenniumSoft is seeking a highly skilled Medical Device Design Control Specialist to join our team. The successful candidate will be responsible for developing and implementing new products through adherence to established design control processes and good engineering and documentation practices.

Key Responsibilities

Demonstrates working knowledge of Engineering principles and its application in solving standard technical problems.
Demonstrates working knowledge of product design and development.
Demonstrates working knowledge of design control process.
Tests, analyzes and solves technical problems with moderate guidance. Applies basic statistical techniques and utilizes design of experiments with moderate guidance.
Translates customer needs into design inputs; verifies design output meets design input. Works with moderate guidance.
Translates requirements into basic designs under the guidance of others. Creates and tests prototypes.
Maps the intellectual property landscape.

Requirements

BS in Mechanical Eng. or Biomedical Eng is required
MS in closely related field is preferred
3+ years of experience in Medical Device Industry working in Product Development/ R&D
Must have participated or led Product Development projects and established a successful track record
Ability to gather user needs, translate them to technical inputs
Develop viable V&V (Design Verification and Validation) plans
Working knowledge of Medical Device Risk Management
Proven ability to assess root cause of issues and propose solutions
Able to foresee project risk and develop mitigation plans
Self-Starter, Agile, Flexible, Quick Learner
Good Communicator, Good Listener
Strong Work Ethic and practices client Values

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