
James Germono
Senior Product Development Engineer with 14+ years of experience with a solid educational background in engineering seeking the... | 1267 Lodestone Drive, San Jose, United States
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James Germono’s Emails jg****@re****.com
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James Germono’s Location 1267 Lodestone Drive, San Jose, United States
James Germono’s Expertise Senior Product Development Engineer with 14+ years of experience with a solid educational background in engineering seeking the role of Senior R & D Manager in medical and biomedical devices. Extensive experience in design, prototype, and diverse engineering arenas, not limited to product management, manufacturing, product and new product development, and testing. Strategize and define requirements aligned with GMP and FDA/MDD that enhance productivity and profitability. Reputation for solving problems with creativity and out-of-the-box solutions. ⫸ Strategic Planning & Direction ─ Demonstrated Subject Matter Expert and leadership role in integrating the client's goals and needs with the product development. ⫸ Research & Development ─ Identified opportunities, researched and recommended new products/methods for medical devices. Generated comprehensive Safety and Development per QSR and ISO standards. ⫸ Staff Training ─ Drove productivity and enhanced product development by delivering training to key personnel regarding standard procedures for product testing, statistical analysis, and Quality system regulations applying multidisciplinary approaches. ⫸ People Management ─ Aligned the organization’s resources/staff to capture the adaptive capability of emerging marketing opportunities, raised efficiency and improved morale ⫸ Project Management ─ Provides design, project planning, and implementation for various medical device projects that have a significant impact on improving operations, efficiency, and profits. ⫸ Process Optimization ─ Astute understanding of engineering design; develop a strategy to improve clients' technology-enabled capabilities, save money, and enhance the business partnership. ⫸ System Development ─ Astute understanding of SDLC; aims to produce high-quality systems that meet or exceed customer expectations. Specialties: ✔ Concept to deployment and commercialization ✔ Medical and Operation Room equipment and integration ✔ Customer focus and Savvy ✔ Product Life Cycle ✔ Reliability and Quality Technical Competencies: ✔ Process Engineering, Quality and improvement plans for Consumer ✔ HALT/ HASS testing ✔ xFEMA analysis ✔ NPI for systems and technologies ✔ HW Quality and Sustaining Engineering ✔ Service Team training Certifications: ✔ All Access Vendor Credentials ✔ XpressO Software Certification ✔ SOLE – The International Society of Logistics Training ✔ Integrated Logistics Systems Training ✔ Hardware Risk Management Training ✔ ISO 9000 Quality Management
James Germono’s Current Industry Reflexion Medical
James
Germono’s Prior Industry
Reflexion Medical
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Quantum3d
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Itt
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General Dynamics Advanced Information Systems
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Workday
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Steris
|
Specific Diagnostics
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Meraqi Medical
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Work Experience

Reflexion Medical
Senior Product Development Engineer
Mon Feb 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Meraqi Medical
Sr Products Development Engineer
Sun Mar 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Feb 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Specific Diagnostics
Principal Systems Engineer
Sun Sep 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Mar 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Steris
Advance Systems & Test Engineer
Fri Aug 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Aug 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Workday
Sr. Application Developer
Wed Jan 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jul 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)
General Dynamics Advanced Information Systems
Senior Ils Systems Engineer
Tue Sep 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jun 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time)
Itt
Hardware Engineer
Fri Jun 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jun 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time)
Quantum3d
Prodct Test Enginer
Thu Feb 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jun 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time)
Reflexion Medical
Senior Product Development Engineer
— Present