For the given job description <<The Opportunity
QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most  home to hospital, lab to clinic.
Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.
The Role
As we continue to grow as QuidelOrtho, we are seeking a self-driven, proactive Staff Electrical Engineer to join our R&D Instrument Platforms organization to provide technical responsibility for Sustaining Engineering (lifecycle management) activities and improvement of our portfolio of products. The individual should have an eye for creating custom engineering solutions and be well-versed in all of the R&D change control processes while driving results within the project constraints of schedule, cost, performance, quality, and reliability objectives under guidance of senior staff. This position is located in Rochester, NY.
The Responsibilities
Support existing product field issues through root cause analysis and continuous improvement.Support existing products and their production line via obsolescence resolution from standard drop-in replacements to board, harness, and other electrical redesigns.Drive projects through our change control process, ensuring completion of all activities within compliance i.e., formal design reviews, FMECA reviews, design verification, EMCSafety Testing, etc.ManageDrive multiple projects in parallel, driving results in a timely manner to maintain the production line and customer satisfaction.Performs other work-related duties as assigned.
The Individual
Required
Minimum of 7-9 years of experience with a Bachelors degree in Electrical Engineering or equivalent combination of education and experience.Demonstrated ability in technical analysis including evaluation of multiple candidate solutions and evaluation of intangibles.Demonstrated ability to assess and manage incoming workloads.Ability to propose methods, techniques, and evaluation criteria to realize product functionality.Ability to work well in a team environment.Excellent organizational skills.Excellent communication, influencing and conflict resolution skills.Experience with technical writing and English fluency.Ability to triage product issues and perform root cause investigations.Adapt quickly to obstacles and changing demands.
Preferred
Experience with design tools such as OrCAD and Altium.Design and implementation of digital and analog circuits.Design for and testing of EMIEMC requirements.Experience with optical systems.DesignKnowledge of stepper motor driver circuits and servo controllers.
The Key Working Relationships
Internal: QualityRegulatory, Operations, Marketing, Manufacturing, Service, Valuemetric, Clinical Medical Affairs, Project Management Office.
External: Development and Manufacturing partners, Customers, Manufacturing.
Key Supervisory Responsibilities
Reviews work quality and quantity of others.May Plan work for Electrical Engineer level III andor Technicians.Mentoring of Electrical Engineer level III andor Technicians.Recommends budget amounts.
The Work Environment
Office & Lab environment including a BL2 Lab (Biohazard).Physical Demands  Light (walking, crouching, lifting up to 50lb, etc.).Travel  Up to 10%.
Salary Transparency
Salary range for this position takes into account a wide range of factors including: education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. Salary range for this position is $82,000 to $148,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time) and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.
Equal Opportunity
QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at orthorecruiting@orthoclinicaldiagnostics.com
>> the resume: <<SummaryLooking for an Engineer Engineering position 2 YEARS Food Industry providing guidance on FDA new regulations FSMA.
*2 YEAR hands on FANUC Robots - PALLET TOOL 
*BS in EE + MS Engineering Mgmt. (25% Completed) with 8 years of engineering experience
*3 YEARS on Critical Utilities Project Management - performing Power Distribution System Feasibility Studies to retrofit critical High Voltage equipment as part of a pilot project to develop a more ROBUST and RELIABLE Power Grid Infrastructure; Design a centralized UPS to provide redundant power to a HPLC lab to reduce the risk during Voltage fluctuations; Design and implement a Power Quality Management System to continuous monitoring the incoming power from Utility company; Design a SCADA to monitor the complete Power System Grid including the following equipments, but not limited to: Backup Generators, UPS, Main Switch Gears, ATS and Main Distribution Panels. Develop a Reliability Program to provide power redundancy to all critical Utility Systems such as (Boilers, Clean Stem Generators, UV Light System and Reverse Osmosis). Conduct a Grounding and Bounding Feasibility Study to facility in order to ensure employees SAFETY. 
*5 years of hands-on PLC, HMI, SCADA for DCS and BMS - Wonderware, iFix, iBatch etc programming experience including: Siemens S7, ControLogix, SLC500, SLC 5, Logix5000. Expertise with ISA 88 Batch standards
*Experience with SQL database used for data-logging and reports at Wyeth.
*Commissioned and started up solid dosage Niro atomizer at Janssen, Puerto Rico as a system integrator 
*2.5 years of Automation Project engineering experience with PLC SCADA for critical power monitoring system. Handled complete project cycle including customer requirements, estimating/proposal support, functional system spec development, customer approval process, control panel hardware design, review P&ID's , field instrumentation specification/selection,  in house FAT with customers, site commissioning and startup assistance, validation support as needed, final training and documentation support
*5.5 years of BioPharma Industry experience with production support and troubleshooting. Supported multiple shift production environments at Pfizer, Wyeth, Janssen and Baxter
*2 years of Control System Validation experience with IQ, OQ protocols and cGMP Regulations
*Extensive experience on Control System Designs including hardware,  Electrical Panel Design and Field Instrumentation
*Excellent team player. Work well with management, vendors, contractors and production personnel.
*Ready to relocate 
QUALIFICATIONS 
Analytical and skilled Controls System / Automation Engineer with a background on pharmaceutical manufacturing process with management experience and Power Systems project management.
*Regulations & Compliance: Expert specializing in cGMP's, OSHA, and FDA regulation compliance. Analyze plant, manufacturing and equipment needs. Develop most economic and cost-effective methods; specialize in facilities design and work measure and methods. Proficient in enhance return of investment. 
*Engineering Methodology: Skills include develop, evaluate and implement cost-effective equipment's to ensure that GMP facilities and biotechnology environment meets all regulated agencies compliance. Also include Automatic Equipment troubleshooting, Emerson Delta V, Rockwell Automation RS Batch, 
RS View, RSLinx, Allen Bradley Device Net, Allen Bradley Variable Frequency Drives, PID Controller Tuning, SCADA and HMI Design (Wonderware, iFix, RSView, Insight), Ladder Logic (PLC) interpretation / development; as well as P&IDs interpretations/analysis. Knowledgeable in Sterilization Process, Filling Machines, Vial Washers, Sterilization Tunnels, Cleaning in Place, Pressure Test, area models for Batch recipe processes.  
continued.
AMIR   E. Claire SOTO
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*Project Management: Excellent skills in project coordination, team leadership, process improvement, as well as technical engineering project deployment and reliability. Skilled in unearthing data and translating complex information into clearly understandable language. Cost Consciousness - Works within approved budget; Develops and implements cost saving measures; Contributes to profits and revenue; Conserves organizational resources. 
*Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
*Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed. 
*Judgment - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions. 
*Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity. 
*Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans. 
*Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics. 
*Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
*Project Management - Develops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time and budget; Manages project team activities. 
*Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality. 
*Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
SkillsJava, C++, Excel, Power Point, Word, Word Sampling, Visio Studio, and AutoCAD; other skills include Allen Bradley PLC programming and troubleshooting, PLC5, SLC500, ControlLogix 5000, DCS, BMS and Data Historian Systems programming and configuration, familiar with Intellution Fix32, Wonderware environment, Foxboro AW, Siemens Insight installation and configuration knowledge. Some knowledge of MSDE manager - SQL Datalogging and reports. Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
ExperienceElectrical Automation / Maintenance Engineer,08/2013to11/2014Marriott International–Marco Island,FL,Responsible for developing, evaluating and implementing cost-effective power quality equipment, facility and utility engineering projects that support manufacturing operations in a dynamic, fast-paced cGMP, biotechnology environment.This includes all phases of the project including conception, developing justification, presenting to management, preparation of the capital request, budget management, project timeline creation and management, detailed design and vendor/contractor scopes-of-work (RFQs/RFPs), competitive bidding, placing purchase orders, contractor and consultant supervision, installation, commissioning, debugging, optimization, supporting Validation and training maintenance and manufacturing personnel.In addition, responsible for providing day-to-day technical support for manufacturing issues that arise including troubleshooting equipment and systems as well as supporting investigations.Upgrade the facility Power Distribution grid by segregating manufacturing bioscience suites to be independent on power source to allow PMO to perform shutdown projects independently without affecting or compromise business and implement redundant power source to feed loads.Design and implement a Power Quality Management System to reduce equipment's failures and reduce NCR's or PR during power interruptions.Design and create a network infrastructure to add all power distribution equipment's on LAN and perform in an easy and Automated Preventive and Corrective Maintenance.Equipment's such as UPS, Power Generators, Automatic Transfer Switch, VFD's and Main Switch Gears.Modify and upgrade SOP to align them with the technician's execution to be in compliance with regulatory agencies.Including PPE requirements to comply with OSHA.Identify power system deficiencies and vulnerabilities in less than 2 months of work, design and implement cost effective solutions to cover the existing gaps in the power distribution grid.Reduce department WO and PM backlogs within less than 3 month finalized numerous projects to completion, led a migration of a human machine interface application for freeze dryers and installation of an AW for the Foxboro control environment of the aseptic area during company shutdown.Incorporate Laboratories equipment into a monitoring system to detect any failure during process and provide fast response.Successfully upgrade the entire pneumatic tubing system of the Fill Line including Vial Washer, Sterilizer Tunnel, VHOP Isolator and Fill Line in a 100% rating of backups for PLC's and HMI computers; tuned a PID on a PLC for the optimization of a process.Reduced and eliminated bottlenecks in manufacturing, improving space utilization metrics.Updated and ensured the on-going data; processes and maintains process documentation.Acted as the primary point of reference for questions, problems, and suggestions.Investigate and analyze customer problems then create Reliable improvement recommendations.Oversee all work performed including preventative, corrective, calibrations, automation changes and Engineering change requests.Able to contribute to cost estimating of major capital budget items and control spending of approved project funds.Create Life Cycle documents (functional specifications, design specifications).Create and modify SOPs for utility systems and automated process systems.Project Manager,11/2012to01/2013MILLENNIUM MAINTENANCE–,,Electrical Project Manager for construction projects develop by contractors in Manhattan and Brooklyn.INDEPENDENT CONTRACTOR,01/2012to05/2012AMIR E. SANTIAGO SOTO–,,Professional Service to Pharmaceutical Industries
Perform as Automation Consultant for Pfizer Carolina and Guayama site, Janssen Gurabo, Merch Las Piedras.Provide consulting services for systems integration, new equipment's installation, start-up and computer systems validation.Also provide recommendations during FAT.PFIZER, CAROLINA, PUERTO RICO    APRIL 2011 MAY 2012
Professional Service as Metrology Standards Controller
Perform as controller to the site Calibration Standards Off/Site calibration logistic.Assure that every standard be sent for calibration 60 days before due date in order to be in compliance and keep the stock up to date on instrumentations.Conduct MIR on every Out of Tolerance condition in order to evaluate the possible product impact by performs a Reverse Traceability on the Calibration Standard Manager "CALMAN".Provide costumer service when required for any field support during manufacturing.Provide support to Technology IQ, OQ and PQ when required.WYETH-AYERST LEDERLE, CAROLINA, PUERTO RICO    MARCH 2006  NOVEMBER 2009
Instrumentation & Process Controls System Engineer II
Conduct extensive troubleshooting, maintenance, configuration and monitoring of various manufacturing equipment, packaging and utilities in compliance to cGMP procedures.As part of a critical 10-member team, oversee and lead all areas of Automation, Process Engineering and Systems Engineering.Train, Manage and mentor operators and mechanics in company SOPs.Drive and evaluate technical concepts to verify optimal operational effectiveness.Manage and allocate resources; ensure timely project deliverables.Assess and evaluate the integration of all manufacturing control systems to a central Uninterruptible Power Supply system (UPS), conduct load analysis for cost reduction project to reduce a 40% the energy consumption, electrical equipment damage prevention, and process improvements.Perform as a leader on an experimental project for an aseptic area Filling Machine Lines to avoid the vials falling during manufacturing, in order to reduce the production hours and obtain a better machine performing as an Instrument & Control System Engineer.Finalized numerous projects to completion, led a migration of a human machine interface application for freeze dryers and installation of an AW for the Foxboro control environment of the aseptic area during company shutdown.Incorporate Laboratories equipment to a monitoring system to detect any failure during process and provide fast response.Conceptualized, planned, and introduced a stopper processor machine (Huber) that utilized silicone emulsion for the dosing, recommended and successfully implemented a direct silicone dosing for the process.Successfully attained a 100% rating of backups for PLC's and HMI computers; tuned a PID on a PLC for the optimization of a process.Reduced and eliminated bottlenecks in manufacturing, improving space utilization metrics and increasing resource allocation optimization.Updated and ensured the on-going data; processes and maintains process documentation.Acted as the primary point of reference for questions, problems, and suggestions.Assembled and maintained change and problem history records; prepared statistics and trend reports.Collaborate on the implementation of OSI PI Data Historian system.Dramatically increased department productivity by reducing down time of manufacturing equipment.Leader of a technical project on an aseptic area vial filling machine to perform the reduce of falling vials during manufacturing.Perform as a project leader on a SCADA upgrade from iFix 32 to iFix 4.0 platforms for Freeze Dryers systems and also for BOSCH filler machine using Wonderware.Upgrade site SIEMENS BMS platform by incorporate DCS system to site network.Reduce external sub-contracts by performing and develop most of the sub-contract activities such as BOSCH Filler TPF computer replacement and startup, Siemens BMS computers rebuilding and reconfiguration.Electrical Installation Assistant,01/2004to01/2005JUAN F. GARCIA INC–City,,Puerto RicoProvide technical support on electric project at Carraizo Dam, Trujillo Alto, and Puerto Rico.Provide support during the relocation of a power sub-station and  installation of six generators of 1GVA of power.
Education and TrainingMSEM:,Expected into-,GPA:Master:Engineering Management,Expected intoPOLYTECHNIC UNIVERSITY OF PUERTO RICO-Hato,GPA:Engineering ManagementBSEE:,Expected into-,GPA:Bachelor of Science:Electrical Engineering,Expected in2005toPOLYTECHNIC UNIVERSITY OF PUERTO RICO-Hato,GPA:Electrical EngineeringElectrical Degree:,Expected in2005to-,GPA:LICEO DE ARTE Y TECNOLOGIA OF PUERTO RICO, Hato Rey, Puerto Rico
Yellow Belt Six-Sigma
YELLOW BELT CERTIFIED, CALIFORNIA, USA:,Expected into-,GPA:
SkillsAutoCAD, Automation, biotechnology, budget management, budget, C++, Calibration, oral, competitive, Consultant, consulting, contracts, Controller, cost reduction, debugging, documentation, Engineer II, Engineer, engineering projects, estimating, fast, FAT, Filling, functional, funds, IQ, Java, LAN, mentor, Excel, Power Point, Word, migration, network, optimization, OQ, OSI, packaging, personnel, PLC programming, PLC, PLC5, Power Distribution, Power Supply, PQ, presenting, PR, Process Engineering, processes, programming, project leader, quality, Quality Management, SCADA, SIEMENS, Six-Sigma, SOP, SQL, statistics, supervision, Switch, Systems Engineering, systems integration, technical support, technician, TPF, trend, troubleshooting, Upgrade, utilities, Validation, Visio, Wonderware, written>>. The result is, 

Fit assessment: No Fit