Principal Systems Project Manager

Company: Island Staffing
Location: Aliso Viejo
Posted on: March 20, 2020

Job Description:

Job Purpose Lead 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 KOLrsquos 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 VV, inputoutput trace matrix, risk management documentation, and validation. Identify and manage technical, manufacturing and commercial viability risks. Education Bachelorrsquos Degree or equivalent in Systems Engineering, Electrical Engineering, Optical Engineering, or Physics. A Masterrsquos 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.

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