Principal Development Engineer

2 weeks ago

Morris Plains, United States Engineering Resource Group Full time

Description
Contract position for a Principal Development Engineer to lead product development efforts within the R&D team for electromechanical medical devices.
Responsible for design and development activities.
Lead and guide multidisciplinary device pipeline and development projects.
Develop Class III electronic medical device products.
Define and generate design and product requirements leading to concept development.
Provide feasibility assessments including prototyping and testing, application of preclinical studies, and leadership of verification and validation activities.
Drive product development through the entire lifecycle, hands on execution, and team leadership.
Oversee development of systems architecture, develop prototypes, analyze and design electronic and electro-mechanical sub-assemblies and prepare cost estimates on proposed design products.
Ensure compliance of product development activities and associated documentation with regulatory requirements, quality standards, and relevant industry guidelines (FDA, ISO, etc.).
Assist manufacturing in the transition from development into production.
Manage procurement of design and testing prototypes from manufacturing partners, external vendors and suppliers
Work with RA and QA on establishing biocompatibility and validating cleaning and sterilization.
Requirements
BS Electrical, Mechanical, or Biomedical Engineering
Minimum 14 years of experience.
Masters degree or PhD is a plus.
Experience developing a range of electronic medical devices through commercialization.
Experience with Class III medical devices preferred.
Understanding of both electrical and mechanical engineering principles, including electrical safety, electromagnetic compatibility and biocompatibility.
Experience managing projects involving embedded microcontrollers, software design, hardware architecture, control feedback circuits, sensors, circuit design, and mechanical elements.
Experience writing and delivering reports and technical summaries supporting clinical submissions as well as submissions to applicable regulatory agencies.
Strong working knowledge of principles and practice of Design Controls (21 CFR 820.30 / ISO 13485), Risk Management (ISO 14971) and US medical device regulations and standards.
Previous experience with IEC 60601-1, IEC 60601-1-2 and ISO 10993-1 desired.
Experience with SolidWorks for 3D CAD modeling, detailed engineering drawings, and GD&T.
Knowledge of computational analysis (FEA, system modeling, etc) and descriptive statistics helpful.
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