MesaRecruiter Since 2001
the smart solution for Mesa jobs

Senior Systems Engineer

Company: Merz Pharmaceuticals
Location: Mesa
Posted on: March 28, 2020

Job Description:

ESSENTIAL DUTIES AND RESPONSIBILITIES


  • Technical liaison responsible for overall system architecture design and performance.
  • Oversees the requirements management process to ensure continuity, testability and traceability (including change control) among all user, system, and technical requirements, and ensures all requirements are properly documented.
  • Establishes a requirements management framework and drives the selection, implementation and oversight of all requirements management tools.
  • Authors all systems-level performance requirements, accounting for applicable, external test standards.
  • Owns verification and validation trace matrix and ensures traceability of all design inputs to design outputs.
  • Applies systems-level expertise to the risk management process as part of the multidisciplinary team of mechanical, electrical, hardware, firmware, software, quality and regulatory subject matter experts.
  • Leads system integration and verification test planning process and the creation of a high-level verification test plan.
  • Develops effective verification strategies and test protocols for each system test, oversees testing and generates verification test reports.

    KNOWLEDGE, SKILLS, AND ABILITIES

    • Clear understanding of systems design and development for complex mechanical and electrical medical devices. - Required
    • Demonstrated ability to author and manage systems-level requirements and specifications in a highly methodical and organized manner. - Required
    • Strong comprehension of risk management and risk analysis techniques, consistent with ISO 14971, applied to medical devices. - Required
    • Strong comprehension of systems-level standards including IEC 60601-1. - Required
    • Thorough understanding of Design Controls (e.g. 21 CFR 820:30). - Required
    • Thorough understanding of verification strategy and test planning. - Required

      KNOWLEDGE OF METHODS

      • Thorough understanding of the product development process. - Required
      • Familiarity with test method validation strategy and supporting statistical analysis. - Required
      • Familiarity with common engineering design and analysis tools. - Required
      • Familiarity with common manufacturing methods, both for mechanical and electrical components. - Required

        PROFESSIONAL EXPERIENCE

        • Minimum of 10 years of engineering experience in the medical device industry. - Required
        • Minimum of 3 years of experience as a systems engineer or equivalent role. - Required
        • Full development lifecycle experience (concept to commercialization) with at least two medical devices. - Required
        • Experience collaborating with design partners/contract engineering firms to design and develop a medical device. - Required
        • Experience with oversight of contract test agencies, including problem resolution, for standardized testing. - Required
        • Experience with medical devices with integrated software, hardware, and firmware. - Required
        • Exposure to usability and human factors testing including IEC 62366. - Preferred
        • Exposure to packaged and/or structured requirements management tools. - Required
        • Exposure to software development practices and IEC 62304. - Preferred
        • Excellent verbal and written communication. - Required
        • Proficient with Word, Excel, PowerPoint, and Project. - Required

          EDUCATION

          • Bachelor's degree in Systems, Mechanical or Electrical Engineering, or a related field. - Required
          • Master's degree in Systems, Mechanical or Electrical Engineering, or a related field. - Preferred


            Requirements


            • Minimum of 3 years of experience as a systems engineer or equivalent role.\n
            • Minimum of 10 years of engineering experience in the medical device industry.

Keywords: Merz Pharmaceuticals, Mesa , Senior Systems Engineer, Accounting, Auditing , Mesa, Arizona

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Accounting, Auditing Jobs


Business (Finance, Accounting, Economics) Tutor (more than $1k/mo)
Description: Varsity Tutors is looking to contract with tutors to connect with clients across a variety of academic subjects and major test prep through Varsity Tutors--- platform. There
Company: Varsity Tutors
Location: Tucson
Posted on: 04/2/2020

Bus. Risk and Control Officer - Technology Risk - 3rd Party
Description: Job Description br Important Note: During the application process, ensure your contact information email and phone number is up to date and upload your current resume when submitting your application (more...)
Company: Wells Fargo Bank
Location: Paradise Valley
Posted on: 04/2/2020

Loan Servicing Specialist 3
Description: Job Description br Important Note: During the application process, ensure your contact information email and phone number is up to date and upload your current resume prior to submitting your application (more...)
Company: Wells Fargo Bank
Location: Phoenix
Posted on: 04/2/2020


Apps Systems Engineer 5
Description: Job Description br Important Note: During the application process, ensure your contact information email and phone number is up to date and upload your current resume when submitting your application (more...)
Company: Wells Fargo Bank
Location: Tolleson
Posted on: 04/2/2020

Bus. Risk and Control Officer - Technology Risk - 3rd Party
Description: Job Description br Important Note: During the application process, ensure your contact information email and phone number is up to date and upload your current resume when submitting your application (more...)
Company: Wells Fargo Bank
Location: Tolleson
Posted on: 04/2/2020

Loan Servicing Specialist 3
Description: Job Description br Important Note: During the application process, ensure your contact information email and phone number is up to date and upload your current resume prior to submitting your application (more...)
Company: Wells Fargo Bank
Location: Litchfield Park
Posted on: 04/2/2020

Loan Servicing Specialist 3
Description: Job Description br Important Note: During the application process, ensure your contact information email and phone number is up to date and upload your current resume prior to submitting your application (more...)
Company: Wells Fargo Bank
Location: Tolleson
Posted on: 04/2/2020

Loan Servicing Specialist 3
Description: Job DescriptionImportant Note: During the application process, ensure your contact information email and phone number is up to date and upload your current resume prior to submitting your application (more...)
Company: Wells Fargo Bank
Location: Phoenix
Posted on: 04/2/2020

Business Risk and Control Senior Associate - Technology Risk
Description: Job Description br Important Note: During the application process, ensure your contact information email and phone number is up to date and upload your current resume when submitting your application (more...)
Company: Wells Fargo Bank
Location: Phoenix
Posted on: 04/2/2020

Loan Servicing Specialist 3
Description: Job DescriptionImportant Note: During the application process, ensure your contact information email and phone number is up to date and upload your current resume prior to submitting your application (more...)
Company: Wells Fargo Bank
Location: Litchfield Park
Posted on: 04/2/2020

Log In or Create An Account

Get the latest Arizona jobs by following @recnetAZ on Twitter!

Mesa RSS job feeds