Job Listing

  • Document Control Specialist

    Location: Coventry, Rhode Island

    Leading manufacturer of medical devices has an immediate need for a Document Control Specialist. This is a 6 month contract opportunity located in Coventry, Rhode Island.

    • Duties Include:
      • Write the records ID, Retention and Storage Procedure.
      • Set up an account with Iron Mountain.
      • Implement the process for storing records in the record retention room.
      • Implement process for storing records to Iron Mountain.
      • Perform 100% inspection of documents being stored (approximately eight pallets of banker boxes).
      • Ship all records > 2 years old to Iron Mountain.
      • Organize all records < 2 years old in the document Archive room.
      • Possibly write the document approval procedure.

    Background Required:
    Must have experience with document control. Medical device and/or pharmaceutical experience is highly desired.

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  • Software Validation - CAPA Coordinator

    Location: Coventry, Rhode Island

    Leading manufacturer of medical devices has an immediate need for a Software Validation - CAPA Coordinator. This is a 6-12 month contract opportunity located in Coventry, Rhode Island.

    Candidate must be skilled with CAPA and documentation practices. Medical device and/or pharmaceutical experience highly desired.

    Candidate must be able to be a leader of the CAPA process, and “drive” the process with minimal direction.

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  • Systems Engineers – INFOSEC

    Location: Camden, New Jersey

    Immediate need for Systems Engineers – INFOSEC. These are 3-6 month contract opportunities located in Camden, New Jersey.

    • Background and Knowledge:
      • Proficient in requirements analysis and development.
      • Proficient in specification development (requirements and interface).
      • Knowledgeable in HW and SW processes and their interaction.
      • Proficient in the development of test plans, procedures and reports.
      • Proficient in systems design.
      • Proficient in the development of security related documentation (TEO, TOC, FSDA, CV, etc.).
      • Knowledgeable in cryptographic principles (algorithms, etc.).
      • Knowledgeable in RED/BLACK separation principles and in TEMPEST design principles.
      • Knowledgeable in Fail-Safe Design Principles.
      • Knowledgeable in Unified INFOSEC Criteria Principles (includes Orange Book).
      • Demonstrated ability to do security assessments; experience developing doctrine
      • Knowledgeable in Common Criteria.
      • Knowledgeable in Secure Design Principles.
      • Knowledgeable in Communications Theory and Communication Protocols.
      • Knowledgeable in the DITSCAP Process.
      • Knowledgeable in DoD Systems and communications/network infrastructure.
      • NSA certification-experienced highly preferable.
    • Requirements:
      • 4 Year Degree (BSEE)
      • MS/PhD preferred
      • 10-15 years of experience
      • Active Secret Clearance REQUIRED

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  • Software Engineers

    Location: Camden, New Jersey

    Immediate need for Software Engineers. These are 3-6 month contract opportunities located in Camden, New Jersey. These positions require candidates that are implementers, with strong code and unit test experience.

    • Requirements:
      • Top Secret Clearance with Special Access (TS/SCI) REQUIRED.
      • Must be an implementer with strong code and unit test.
      • Clearcase, C++, Greenhills Integrity, and Key Management required.

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  • Controls Engineer

    Location: Chicago, IL

    Immediate need for a Controls Engineer. This is a direct hire (permanent) opportunity located in the Chicago, IL area.

    • Qualified candidates will provide project based engineering services in the following areas:
      • Manufacturing Automation & Intelligence - this entails PLCs, Motion Control, Machine Vision, Robotics, SCADA, MES, etc.
      • Test & Measurement Automation - this is primarily providing LABVIEW development.
      • Custom Software Engineering - working on product development for stand-alone and embedded applications using development environments including C#, VB, C++, etc.
    • Requirements:
      • 3-5 years (minimum) experience as a project-based Controls Engineer.
      • Superlative academic credentials with an undergraduate degree from a Tier 1 school.
      • High level programming experience in PLCs, Servo Control, Machine Vision, MES/SCADA, and LABVIEW.
      • MS Development experience including: Visual Studio, .NET, VB, C#, C++
      • SQL Server experience highly beneficial.
      • Willingness to travel up to 50%.
      • Excellent customer facing skills.

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  • Digital / Analog Engineer

    Location: Northridge, California

    Leading manufacturer of medical devices has an immediate need for a Digital/Analog Engineer. This is a 12 month contract opportunity located in Northridge, California.

    • Duties Include:
      • Developing firmware/software for medical applications
      • Executing unit, integration, and verification testing
      • Identifying opportunities for productivity and quality improvements
      • Participating in technical reviews and provides technical leadership
      • Preparing and maintaining formal documentation
      • Responsibility for the analysis, development and test of complex digital and analog sub-systems (discrete and /or chip design) for ultra low power battery operated microprocessor controlled medical devices including power supplies, sensor interfaces, A/D conversion and RF telemetry.
    • This position will focus more on analysis and test of new embedded microcontroller systems and their components, with the opportunity to improve performance, reliability and quality.
      • Emphasis on analog circuits and systems integration including motors, state of the art communication, display and audio capabilities.
      • Evaluate and select components, and generate component, functional and test specifications.
      • Power usage characterization and analysis of noise and its impact on system performance.
      • Includes hands on laboratory

    Requirements:
    Demonstrated ability in creative design engineering and thorough testing of designs accompanied by detailed functional specifications, test specifications and test reports in compliance with medical regulatory standards.

    Results, quality and process driven with excellent communication skills, developing and maintaining constructive collaborative relationships with cross functional departments.

    • Undergraduate degree required.
    • 3-5 years of medical device experience.
    • Experience with Mentor, Analog, Board Layout, Digital, Library, Multi-Layer, OrCad, PC Board Design, Schematics, Surface Mount, Circuit Design, Component Failure Analysis, and Component testing required.

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  • Process Technician

    Location: Northridge, California

    Leading manufacturer of medical devices has an immediate need for a Process Technician. This is a 3 month contract opportunity located in Northridge, California.

    • Duties Include:
      • Performing test and measurement activities using established test methods or written protocols.
      • Comparing results against predetermined limits and write clear and accurate test result reports.
      • Troubleshooting and fault isolate equipment.
      • Coordinating schedules within work group and with other departments.
      • Possessing good attention to detail and task organizational skills
      • Operating well in a team environment.
      • Supporting automated equipment for new consumable reservoir for infusion system.
      • Providing direct support to principal automation engineer to assemble and test prototype automation equipment.
      • Maintaining equipment including troubleshooting and documenting test results to support automation engineering.
      • Supporting managers and engineers as needed to support the process improvement efforts, building prototypes/samples, equipment evaluations, equipment qualifications, calibrations and testing.
      • Working directly and closely with principal engineer to ensure the automation engineering needs are met and production line is running at its capacity.
      • Documenting all work performed by utilizing good organizational skills and comply with company and department requirements.
      • Accurately performing technical tasks per written and verbal instructions.
      • Performing complicated tests requiring considerable judgment in determining work methods and interpreting test results with minimal supervision.
      • Performing training to other technicians as needed.
      • Performing electro mechanical assembly and repairs of prototype machinery and equipment as needed.
      • Coordinating calibration activities with operations and metrology depts.
      • Demonstrating technical and interpersonal competencies in utilizing formal methods and processes with respect to mechanical development, testing and implementation.
      • Supporting equipment transfers from suppliers or others including installation, qualifying processes and assist the engineer for eventual validation and deliver training to others.
      • Performing other assignments as needed.
    • Requirements:
      • Experience with Robots is a must for this role.
      • Mechanical Aptitude is REQUIRED, experience with automated equipment a plus.
    • Education Level:
      • Associate Degree
      • High School Diploma or Equivalent

    Industry Experience: 1 - 3 Years

    Software Application Knowledge: MS Excel, MS PowerPoint, MS Outlook MS Word, Windows 98, Windows 2000

    Desired Education Level: Undergraduate Degree

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  • Site Support Engineer

    Location: Harrisonburg, Virginia

    Immediate need for a Site Support Engineer. This is a direct hire (permanent) position located in Harrisonburg, Virginia.

    This position will involve working at customer sites doing programming and writing code. Candidates must be hands on Field Engineers with a strong controls background.

    • Background Required:
      • 5-10 years of experience as Field Engineer or Controls Engineer (Delta V).
      • BSEE or Chemical Engineering degree preferred.
      • Minimum 5 years DCS Engineering experience with DeltaV System.
      • Batch Process knowledge is required.
      • Programming and field device knowledge is required.
      • Strong experience configuring and working with DCS Software.
      • Instrumentation experience required.
      • Candidates must have experience writing and re-writing code.
      • Industrial process experience within the pharmaceutical industry preferred.

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