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Principal Systems Project Manager

Company: Island Staffing
Location: Aliso Viejo
Posted on: May 4, 2020

Job Description:

Job PurposeLead an interdisciplinary team and manage development of an innovative laser-based platform in a focused, fast-paced and fun environment. This position will require you to translate design requirements from concept to manufacturing transfer. Provide in-depth knowledge of complex systems for medical applications, controls and user interfaces.Key Responsibilities

  • Technical leader and manager taking overall project ownership of a complex optomechanical medical console.
  • Develop and maintain a detailed project plan from early project concept phase to regulatory approval.
  • Work with executive management and KOL's to develop marketing specifications and requirements.
  • Write product requirement specifications and ensure successful system integration and validation.
  • Coordinate technical activities for system development between multiple venders and internal resources.
  • Manage internal engineers and manufacturing partners to ensure design input and output requirements are captured.
  • Write and execute V&V, input/output trace matrix, risk management documentation, and validation.
  • Identify and manage technical, manufacturing and commercial viability risks.Education Bachelor's Degree or equivalent in Systems Engineering, Electrical Engineering, Optical Engineering, or Physics. A Master's Degree or PhD can substitute for experience.Minimum Experience
    • 10+ years or more years of experience developing Class II medical systems with a demonstrated track record of bringing medical equipment from concept to market.
    • Strong ability to build and manage project plans and expedite project completion with experience in project leadership.
    • Foundation in system identification, modeling, analysis, architecture, integration and testing.
    • Proficient in Risk Management according to ISO 14971.
    • Solid understanding of Design Controls according to 21 CFR 820 or ISO 13485.
    • Well versed in test standards, including IEC 60601 test requirements.
    • Vendor and supplier management for complex sub-systems, or OEM.Preferred Experience
      • Expertise in Lasers, Photonics, Fiber Optics and Optomechanics.
      • Development of laser systems, fiber optic energy delivery devices, fiber optic probes.
      • Proficiency with industry standard tools and methods for laser and electro-optical systems engineering.
      • Biomedical product or medical device development experience involving high-energy, Q-switched, diode driven fiber optic, or other solid-state lasers and related electronic, optical and optoelectronic equipment.
      • Knowledge of assembly, alignment, powering and test methodologies and related equipment.
      • Experience with Class 3B & Class 4 lasers and related optics for energy delivery and single-use devices. - provided by Dice

Keywords: Island Staffing, Aliso Viejo , Principal Systems Project Manager, Executive , Aliso Viejo, California

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