Senior Test Method Validation Engineer - Remote/Work from home

Ventura Solutions LLC - Vernon Hills, IL, United States

Ventura Solutions is a rapidly growing medical device and pharmaceutical staffing, consulting, and training firm. We believe that the best way to advance healthcare is through innovation and continuous improvement. We value our commitment to solving healthcare's toughest problems and delivering world-class products, services, and human resource solutions. We are a company of problem solvers, inventors, teachers, and friends.

Our company offers an energized, collaborative, optimistic, and fun culture that cultivates an inventive spirit while being committed to exceeding client expectations. We offer tremendous opportunities for career growth, fulfilling projects, excellent salaries, competitive benefits, flexible hours, along with many work from home/remote opportunities. For more information about us visit us at www.ventura-solutions.com

Are You a Medical Device Engineer looking for a remote - work from home opportunity with an innovative and growing Medical Device consulting firm? If interested, we also have on-site positions available.

If you consider yourself to be an engineer with excellent experience in Test Method Validation (TMV) of Medical Devices– WE WANT TO MEET YOU!

The level/title of this position can be adjusted based on the candidate's level of experience.

Experience and passion are what we desire for this role and we're looking for the best! While working in this role you will have the ability to:

Summary

Seeking a highly motivated candidate with technical skills in problem-solving, critical thinking and who is detailed-oriented. Incremental support to our internal Test Method Validation (TMV) team under the leadership and guidance of trained team members. Work in support of quality system improvement initiatives – remediation of quality system documentation, design documentation, standard and technical test methods, DHFs, DTMs, RTMs, etc. Lead the TMV process for variable and attribute physical test methods for products. The work will interact remotely with the research and engineering and laboratory locations for test execution and surrogate development, as well as the execution of validation studies.

          Basic Qualifications

  • Candidate must possess a bachelor’s or advanced degree in an Engineering or Scientific discipline.
  • Knowledge in design controls and change controls for FDA regulated medical devices (21 CFR 820.20 and ISO13485 standards)
  • Knowledge of test method validation (TMV), installation qualification (IQ), and related statistics: study design, DOE, TM characterization, data analysis (Gage R&R, correlation, etc.), test method validation study.
  • Ability to create technical documentation, including TMC, IQ, TMV, and Generic Verification protocols and reports.
  • Knowledge of test fixtures and test equipment such as tensile frames.
  • Excellent written and oral communications. Ability to summarize and consolidate data and information in presentation form for cross-functional discussion.
  • Ability to work remotely with advance proficiency in software applications: MS Office (Outlook, Word, Excel, PowerPoint, and MS Teams), connective applications (Zoom, MS Teams and Skype).
  • Pro-active approach on project management, problem solving and development of Test Method Validation activities.
  • Ability to work autonomously across functional boundaries to complete projects within required timeframes while being part of a team.

         Preferred, but not required, Qualifications

  • Experience in ETQ as a quality system
  • Product knowledge of tampons, pessaries, menstrual pads, wipes, and/or incontinence products
  • Additional experiences with process validation, risk management, and quality systems.
  • Knowledge on test method development and validation: surrogate development and equivalence test
  • Strong statistical analysis skills, Design of experiments (DOE), Minitab.
  • EU and MDR experience with medical devices or combination products.
  • Extensive experience in risk management and design control of medical devices or combination products from concept through launch.
  • Experience or familiarity with drug product development practices required for clinical trials and commercial products.

         Key Leadership Qualifications

  • Strong Communication Skills.
  • Builds strong relationships with peers and cross-functionally with partners to enable higher performance.
  • Strong leadership, negotiation, interpersonal, communication, and facilitation skills.
  • Learns fast, grasps the "essence" and can change course quickly where indicated.
  • Raises the bar and is never satisfied with the status quo.
  • Creates a learning environment, open to suggestions and experimentation for improvement.
  • Proven ability to succeed in a fast-paced, challenging, and complex environment.
  • Embraces the ideas of others, nurtures innovation and manages innovation to reality.
  • Strong interpersonal and communication skills with demonstrated ability to work within a team environment.

    If you can say YES to the above requirements, we want to talk to you – APPLY NOW! We would love to talk about your experience, career goals, and fit with this amazing role.

    Location

    Remote - Work from Home

    Occasional Travel to Menasha, Wisconsin, and potentially other locations.

    Requirements for Home Office

  • Fast internet connection (50MB+)
  • Good cell phone signal in home office
  • Quiet home office with minimal distractions

    Employee Type

    W2 Employee

    We will also consider 1099 engagements

    Benefits

  • Choice of medical dental and vision plans
  • Paid Vacation Time
  • Competitive base salary

    This is a great opportunity and we're looking to fill this role with the right person. If you are ready to embark on an amazing new career opportunity, APPLY RIGHT NOW!

    Offering world-class solutions for our clients is only part of our mission. Providing a rewarding and fulfilling place to work is a top priority for us. From an industry-leading compensation package to a focus on work-life balance, we offer a challenging and flexible place to achieve your career dreams. Make your impact today!

    Equal Opportunity Employer Minorities/Women/Veterans/Disabled



Posted On: Friday, July 15, 2022



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