Jobs
>
Phoenix

    Sr. Software Design Control Engineer - Phoenix, United States - Caris Life Sciences

    Caris Life Sciences
    Caris Life Sciences Phoenix, United States

    3 weeks ago

    Default job background
    Description
    Position SummarySr.

    Software Design Controls Engineer thinks "outside the box" in the implementation of the Software Design Control and SDLC (software development lifecycle) programs at Caris Life Sciences, providing quality oversight, and ensuring compliance with all applicable regulations and incorporations of software industry best practices.

    The position will work in collaboration with the Software Development, Bioinformatics, IT, Information Security (InfoSec), Regulatory Affairs, project/program management, and other cross-functional teams throughout the SDLC.Job ResponsibilitiesSupports the implementation of the SDLC and software design controls as per the requirements of ISO 13485/FDA QSR design controls and IEC 62304.Participates in process improvement of software design controls and other impacted SDLC processes, work instructions and templates.

    This includes the ability to perform gap analysis, impact analysis, and risk communication.

    Provide mentorship, guidance, and training to the software development engineering team members new to medical device regulated software development requirements.

    Leads cross-functional team members performing risk management (including cybersecurity risk analysis) and configuration management activities.

    Authors (as needed) and ensures quality records produced during software development, validation, maintenance activities are in accordance with Quality System Requirements which include IEC 62304, ISO 13485, FDA QSR, 21 CFR Part 11, and GAMP5 requirements.

    Leads by example - the ability to author (as needed) and ensure quality records produced during software validation process are accurate, clear, concise, and sufficient for multiple projects at a time.

    This includes quality oversight on the following documents that support the SDLC processes (as applicable): planning, risk assessment, requirements and specifications, summary reports, trace matrixes, V&V, and cybersecurity related quality records.

    Supports initiative to ensure IT and InfoSec teams maintain compliance to NIST , ISO 27001, and SOC 2.

    This includes participating and collaborating with compliance team members to audit current IT and InfoSec practices and ensuring compliance to processes.

    Maintains collaboration and solid communication channels with internal audits and compliance teams for knowledge sharing purposes and to drive operational efficiencies.

    Participates in Supplier Qualification Audits of software suppliers that will be used to support the development of an Off-the-shelf (OTS) computerized system.

    Partner with a lead auditor to ensure the supplier's software development and validation practices comply with Caris's SDLC process.
    Able to work independently with minimal supervision with objectives given by Software Quality Leadership.
    Plan and coordinate own work according to higher-level project schedule demands.
    Assist in internal, external, and regulatory inspection readiness activities and provide support during audits.

    Performs complaint investigations, root cause analysis, CAPA, closure of audit/inspection observations, and other QMS activities related to software design controls and risk management.

    Required QualificationsBachelor's degree in an engineering, scientific or related field with minimum 4+ years of relevant hands-on experience, or relevant comparable background.

    Strong knowledge of SDLC process and the application of IEC 62304, ISO 13485, FDA QSR, 21 CFR Part 11, GAMP5, and FDA Cybersecurity guideline requirements.

    Knowledge of agile/scrum SDLC methodology and its implementation of SDLC practices in a medical device regulated environment.
    Adaptable to fast-paced, dynamic work environment with shifting demands.


    Conditions of Employment:
    Individuals must successfully complete pre-employment process, which includes criminal background check, drug screening, and reference verification.

    Preferred QualificationsKnowledge of NIST , ISO 27001, and SOC 2Experience with agile SDLC tools such as Atlassian (JIRA, Confluence and various plug-ins) or GitLab.

    Project experience (preferably 2-4 years of experience) in software validation practices, methodologies, and techniques, preferably in validating medical devices.
    Software development experience.

    Experience in successfully leading new software development teams through the software validation and risk management processes, including producing validation quality records.

    Experience in supporting internal, external, regulatory inspections.
    Knowledge of regulations pertaining to CLIA/CAP/LDT labs, Companion Diagnostic (CDx) or NGS (Next Gen Sequencing) is a plus.
    Physical DemandsEmployee may be required to lift routine office supplies and use standard office equipment.
    Ability to sit for extended periods of time.

    Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes and bio-hazardous material in the lab environment.

    Travel may be required up to 10% of the time.
    TrainingAll job specific, safety, and compliance training are assigned based on the job functions associated with this employee.
    This job description reflects management's assignment of essential functions.

    Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

    Caris Life Sciences is an equal opportunity employer.

    All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

  • Amotec Inc.

    Control Engineer

    1 week ago

    Amotec Inc. Arizona, United States

    Amotec is engaged in a search for a Senior Controls Engineer. Located in Tempe, AZ our client is a leading $2B manufacturer experiencing rapid growth This global organization is recognized for its innovative solutions and commitment to excellence, and is seeking a talented profes ...

  • Shermco

    Controls Engineer

    1 week ago

    Shermco Phoenix, United States

    Job Responsibilities and Expectations: · Design of control systems including: Network Architecture · Cause and Effect Diagram · Control Philosophy · SCADA Maps · Programming of control system using PLC and HMI software tools. · Startup/Commissioning of control system (within co ...

  • Hyper Recruitment Solutions

    Controls Engineer

    6 days ago

    Hyper Recruitment Solutions Arizona, United States

    Hyper Recruitment Solutions are seeking a Controls Engineer to join an exclusive southwest manufacture based in Arizona who are expanding there engineering teams due to extensive project expansion. · The Senior Controls Engineer will be involved in the design, programming & maint ...

  • ASM Company

    Controls Engineer

    1 week ago

    ASM Company Phoenix, United States

    ASM is a leading global supplier of products, services, and materials for semiconductor processing. For more than half a century, innovation has been at the core of everything we do. Our smart, ambitious people are dedicated to creating cutting-edge solutions for the world's lead ...

  • Talentrust

    Controls Engineer

    6 days ago

    Talentrust Phoenix, United States

    Title: Controls Engineer · Location: Phoenix, AZ · We are seeking a skilled and motivated engineer to lead technical electro-mechanical integration projects, utilizing a variety of engineering and manufacturing disciplines. This role requires proactive technical and commercial ...

  • Shermco

    Controls Engineer

    1 week ago

    Shermco Phoenix, United States

    About Shermco · Since 1974, Shermco has become North America's largest and fastest growing NETA-accredited electrical testing organization. Our focus is to make sure electrical power systems are functioning properly and safely. Add to that our Professional Engineering Group, Rot ...

  • Talentrust

    Controls Engineer

    6 days ago

    Talentrust Phoenix, United States

    Title: Controls EngineerLocation: Phoenix, AZWe are seeking a skilled and motivated engineer to lead technical electro-mechanical integration projects, utilizing a variety of engineering and manufacturing disciplines. This role requires proactive technical and commercial interact ...

  • HDR

    Control Systems Engineer

    2 weeks ago

    HDR Phoenix, United States

    About UsAt HDR, we specialize in engineering, architecture, environmental and construction services. While we are most well-known for adding beauty and structure to communities through high-performance buildings and smart infrastructure, we provide much more than that. We create ...

  • JCO Workforce Solutions

    Instrumentation and Controls Engineer

    2 days ago

    JCO Workforce Solutions Phoenix, United States

    Job Description · Job DescriptionJCO is currently on the lookout for an Instrumentation and Controls Engineer for one of our top clients This dynamic company is one of the top Electrical Contractors in the construction industry and they are looking for experienced individuals to ...

  • Delta Technology, LLC

    Controls Engineer III

    1 day ago

    Delta Technology, LLC Phoenix, United States

    Job Description · Job DescriptionWHO IS DELTA TECHNOLOGY? · We are experts in robotics and automation. We are passionate about our work. Our continuous goal is to be pioneers in our field and to lead our customers to a better and more efficient future. We do that by providing ima ...

  • Honeywell

    Lead Controls Systems Engineer

    3 weeks ago

    Honeywell Phoenix, United States

    As Lead Controls Systems Engineer within Honeywell Aerospace, you will join a team that designs, develops, and integrates highly complex control systems for the Engines and Power Systems APU business. · Engine & Power Systems develops and produces high-performance propulsion engi ...

  • Pacific Technical Resources Inc

    Flight Control Engineer

    2 weeks ago

    Pacific Technical Resources Inc Phoenix, United States

    Pacific Technical Resources, LLC. · Is your CV ready If so, and you are confident this is the role for you, make sure to apply asap. · IT/Engineering Recruitment Professionals · "Helping to build Great Companies and Great Lives" · We are seeking a direct hire Senior Systems an ...

  • Blue Origin

    Embedded Controls Principal Engineer

    1 week ago

    Blue Origin Phoenix, United States Full time

    At Blue Origin, we envision millions of people living and working in space for the benefit of Earth. We're working to develop reusable, safe, and low-cost space vehicles and systems within a culture of safety, collaboration, and inclusion. Join our diverse team of problem solvers ...

  • Pacific Technical Resources LLC

    Flight Control Engineer

    5 days ago

    Pacific Technical Resources LLC San Francisco, United States Permanent

    Pacific Technical Resources, LLC.IT/Engineering Recruitment Professionals"Helping to build Great Companies and Great Lives" We are seeking a direct hire Senior Systems and Flight Controls Engineer (Autopilot) for a Billion Dollar Leader delivering ...

  • HotFoot Recruiters

    Sr. Controls Engineer

    1 week ago

    HotFoot Recruiters Phoenix, United States

    HotFoot Recruiters has partnered with an Automation Supplier and Integrator in need of a Direct Hire Controls Engineer in the North Phoenix, AZ area. · Position: Sr · Controls Engineer · Location: North Phoenix (Deer Valley area) · Schedule: Monday ??? Friday, 100% in-office, ...

  • HotFoot Recruiters

    Sr. Controls Engineer

    2 weeks ago

    HotFoot Recruiters Phoenix, United States

    HotFoot Recruiters has partnered with an Automation Supplier and Integrator in need of a Direct Hire Controls Engineer in the North Phoenix, AZ area. · Position: Sr · Controls Engineer · Location: North Phoenix (Deer Valley area) · Schedule: Monday ??? Friday, 100% in-office, nor ...

  • Honeywell

    Quality Control Engineer

    3 days ago

    Honeywell Phoenix, United States

    Innovate to address the most crucial challenges worldwide. As a CMM Inspector Level IV at Honeywell, you will play a vital role in ensuring the quality and precision of our products using Coordinate Measuring Machines (CMM). · You will be responsible for conducting intricate insp ...

  • LVI Associates

    Data Center Controls Engineering Lead

    3 weeks ago

    LVI Associates Arizona, United States

    A leading Engineering Design Firm within the Data Center space is strategically growing their systems integration group by developing a PLC/SCADA Controls Group. · Position Description: · Program and Develop Customized PLC Programs for Data Center HVAC Systems in Multiple Platfor ...

  • Carrier Transicold Polska Sp. z o.o.

    BAS Controls Application Engineer

    2 weeks ago

    Carrier Transicold Polska Sp. z o.o. Phoenix, United States

    BAS Controls Application Engineer page is loaded · BAS Controls Application Engineer · Apply · locations · CAWAO: Carrier-Home Washington Remote Location, Remote City, WA, 98001 USA · CAAZO: Carrier - Home Arizona Remote Location, Remote City, AZ, 85012 USA · time type · F ...

  • Carrier

    BAS Controls Application Engineer

    19 hours ago

    Carrier Phoenix, United States

    **Country:** · United States of America · **Location:** · CAA11: ALC West AZ 4615 South 33rd Place , Phoenix, AZ, 85040 USA · Carrier is the leading global provider of healthy, safe and sustainable building and cold chain solutions with a world-class, diverse workforce with b ...