Systems Engineer II

  • Batesville, IN
  • Posted 4 hours ago | Updated moments ago

Overview

On Site
$40 - $45 /hr
Contract - Independent
Contract - 6 month(s)

Skills

("Systems Engineer" OR "V&V Engineer" OR "Verification and Validation Engineer") AND ("Medical Device" OR "Pharma" OR "Pharmaceutical") AND ("Systems Engineering" OR "DOORS" OR "Polarion" OR "Minitab"

Job Details




Stefanini Group is hiring!

Exciting opportunity awaits, let us help you get started!

Click Apply now or you may call Sangeeta Dasadhikary at or email at for faster processing!



Job Description

As part of an R&D project team, the Senior Systems and V/V engineer provides technical contributions to the system design and Verification/Validation of a complex medical device from concept through commercialization and/or through the full life cycle of the product. A senior engineer focuses on defining the customer needs; creating or modifying product system requirements and architecture necessary to meet those needs; evaluates constraints and makes trade off decisions; contributes to the development or modifications to module level design requirements; contributes to the product safety and security risk management activities including DFMEA's; contributes to the identification of technical risks and mitigations, develops the verification and validation plans, protocols, scripts, execution, regression, and reports.

The senior engineer works in close collaboration with the Lead engineer, project manager, and other functional team members to ensure the project/product success. The senior engineer provides guidance to other engineers in design reviews and helps resolve issues.



What you'll be doingPrimary focus of role will be in Systems and V&V Engineering for Sustaining legacy product portfolio and/or new product development responsible for all systems and/or V&V engineering deliverablesGenerate alternatives and take reasonable risks while solving technical problemsComplete detailed, high quality technical documentation to capture and communicate designsSeek knowledge of the business, market, industry and competitive environmentUse existing tools and best practices to report and track product and process metricsInform others proactively about developments or issues that affect their work, and their ability to meet commitmentsOther duties may be assigned



What you'll bringBachelor's degree in engineering3+ years of experienceAbility to generate alternative solutions to problems or processesStrong Interpersonal skills with the ability to work collaboratively with others in a team environmentAbility to adapt to changeGood judgment in selection methods and techniques to acquire resultsKnowledge of Medical Device Regulations and Standards including design control and risk management is preferredProficient in systems engineering tools such as DOORS, Polarion, and MinitabKnowledge of different subject areas making up systems including electrical, mechanical, pneumatic, software, materials, and/or wireless connectivityStrong technical writing and communication skills



Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives



About Stefanini Group

The Stefanini Group is a global provider of offshore, onshore and near shore outsourcing, IT digital consulting, systems integration, application and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like Americas, Europe, Africa and Asia, and more than 400 clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting, company with global presence. We are CMM Level 5 company.



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