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@amgen.com
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Edward Nielsen is listed as Sr. Manager at Amgen at Amgen, based in Ventura County, California, United States. AeroLeads shows a work email signal at amgen.com, phone signal with area code 805, and a matched LinkedIn profile for Edward Nielsen.
Edward Nielsen previously worked as Sr. Manager at Amgen and Principal Engineer at Amgen. Edward Nielsen holds M.B.A., Business Administration from Woodbury University.
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A 29 year engineering career in a regulated environment (FDA, DOD), and safety critical in nature. Experienced engineer and manager with 19 years managing functional teams. Experience in detailed planning with corresponding oversight, risk management, Software V&V, technical design reviews, requirement and other documentation reviews, defect and change management, help line call reviews and analysis, creating and managing budgets, staff allocation and training, legal technical support, and staff morale and motivation.Experience in:• Regulated industries, particularly medical and defense/military (e.g. FDA, CE, DOD). • Risk Management on Drug Delivery Devices and Combination Products• Leading project V&V on real time embedded software systems with wired and wireless communications (e.g. insulin pumps, power management software for the International Space Station.)• Coordinating activities with cross functional teams (e.g. Quality, Risk Management, Software, V&V, Marketing, Engineering, Human Factors, Operations/Manufacturing, Regulatory, Safety, etc.)• Document review and creation (Technical, Plans, Reports, Risk Assessments, etc.)• Scheduling (MS Project) including metrics to enhance predictability.• Develop integrated and cross-functionally linked schedules with corresponding oversight• Establishing and managing budgets• Developing project plans (staffing, process definition/governance, change management, tools selection, etc.)• Working in process driven environments (e.g. IEC-62304, ISO13485, 21CFR820, ISO14971) • Developing applicable procedures to ensure compliance with required design controls.• Technical design reviews and phase gate design reviews, including presentations before applicable review boards.• Defect and Change Management with effort and risk assessments• Experience managing up to 100+ personnel on up to 3 concurrent projects. • Yellow Belt, Six Sigma
Listed skills include Medical Devices, Testing, Fda, Iso 13485, and 46 others.
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Thousand Oaks, Ca, Us
Sr. Manager Combination Product Operations Risk Management team in support of Amgen combination products and medical devices. Perform risk management project and process tasks associated with Amgen product goals and in conformance with regulations. Support internal and regulatory audits.
Thousand Oaks, Ca, Us
Risk Management, including Risk Management Plans, Risk Management Files, Hazard Analysis, Use Risk Assessments, System Risk Assessments, dFMEA, pFMEA and Risk Management Summary Report. Post market analysis. Process & Standards: ISO13485, IEC-62304, 21CFR Part 4, 21 CFR 820 (QSR), HIPAA, IEC60601-1, IEC60601-1-4, IEC60601-1-8, IEC60601-1-11, ISO 14971:2012, ISO11608-4, and processes in conformance with NIST800-30.Yellow Belt, Six Sigma
San Francisco, Ca, Us
Risk Management, including Risk Management Plans, Risk Management Files, Hazard Analysis, User Risk Assessments, System Risk Assessments, dFMEA, pFMEA and Risk Management Summary Report. Worked on Post Market Analysis for planned annual review. Processes and Standards include but are not limited to 21 CFR Part 4 (Combination Devices), 21 CFR Part 820, ISO 13485, ISO 14971:2012, EN60601-1-11.
Minneapolis, Mn, Us
Engineering Manager, May 2005 - 5/10/2015Software Test Lead, 9/24/2001 – May 2005Staff Managed: Varied on projects being worked. Managed up to 105 staff. Budget Managed (Annual): up to $3 MillionTasks: Coordinate with other Departments/Teams, Scheduling/Forecasting, V&V Strategy, Compliance Management, Metrics, Status Reporting, Budgeting, Performance Management, Vendor Coordination/Management, Resource Management/Allocation, Training, Business Continuity Planning, etc. Coordinate with others necessary deliverables needed for IQ/OQ/PQ, as well as DVT and other Reliability testing.Products: Managed the formal V&V of several products, including the MiniMed 620G, 630G, 640G Next Generation Pumps and the entire MiniMed Paradigm series of pumps. Managed formal V&V efforts and supported corresponding product launch preparations.Process & Standards: IEC-62304, ISO13485, 21 CFR 820, 21 CFR Part 11, HIPAA, EN60601-1, EN60601-2-24, ISO14971:2012, etc. Established team processes with uniform and consistent directions to ensure compliance with established external and internal processes and standards. Developed and/or contributed to SOPs and DOPs related to V&V and Software activities.
Arlington, Va, Us
Member of Technical Staff, Lasers and Electro-Optics Software Test Lead, RS-68 Engine Control Software (For Delta IV Rocket)Managed the Software Verification team testing the engine control software. Tools included custom automation, logic analyzer, Lab Windows, and high speed plotting equipment. Project completed on schedule and on budget.Software Test Engineer, International Space Station Power System (PVCA, PMCA)Completed FQT. Software process was per Mil-Std 2167A, with a maturity level of CMMI Level 3 (Working on level 4/5). Designed and wrote test cases (all automated on the MATE test system using a C based script language). Performed dry runs and FQT runs. Designed and set up the test lab for FQT including Mil-Std 1553 network connections.
Washington, Dc, Us
Honorable Discharge - Disability (Line of Duty)Primary MOS: 0352 TOW Anti-Tank MissileSecondary MOS: 0351 Anti-Tank Assault/DemolitionsTOW Co, 2nd Tank Bn., 2nd Marine Division, Camp Lejeune, NC
Other employees you can reach at amgen.com. View company contacts →
Daniel Lee
Colleague at AmgenUnited States
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WM
Wendy Maghooli, Mba
Colleague at AmgenSanta Clarita, California, United States
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Zara Buckley
Colleague at AmgenCounty Dublin, Ireland
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Christopher Fabry
Colleague at AmgenSimi Valley, California, United States
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Isha Khopkar
Colleague at AmgenMumbai, Maharashtra, India
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Rosanne Finley
Colleague at AmgenMedford, New Jersey, United States
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Cat Grey
Colleague at AmgenWashington Dc-Baltimore Area, United States
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Joseph Ahrens
Colleague at AmgenMiami, Florida, United States
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Sarah Clifford
Colleague at AmgenCounty Dublin, Ireland
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Ellen Mccroskery
Colleague at AmgenWestlake Village, California, United States
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Quick answers generated from the profile data available on this page.
Edward Nielsen works for Amgen.
Edward Nielsen is listed as Sr. Manager at Amgen at Amgen.
AeroLeads has found 2 work email signals at @amgen.com for Edward Nielsen at Amgen.
AeroLeads has found 3 phone signal(s) with area code 805 for Edward Nielsen at Amgen.
Edward Nielsen is based in Ventura County, California, United States while working with Amgen.
Edward Nielsen has worked for Amgen, Pro Unlimited, Medtronic, Boeing, and United States Marine Corps.
Edward Nielsen's colleagues at Amgen include Daniel Lee, Wendy Maghooli, Mba, Zara Buckley, Christopher Fabry, and Isha Khopkar.
You can use AeroLeads to view verified contact signals for Edward Nielsen at Amgen, including work email, phone, and LinkedIn data when available.
Edward Nielsen holds M.B.A., Business Administration from Woodbury University.
Edward Nielsen is listed with skills including Medical Devices, Testing, Fda, Iso 13485, Quality Assurance, Cross Functional Team Leadership, Engineering Management, and V&V.
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