What are the responsibilities and job description for the Systems Engineer II position at Stefanini North America and APAC?
Details:
Job Description
Stefanini Group is hiring!
Exciting opportunity awaits, let us help you get started!
Click Apply now or you may call Sangeeta Dasadhikary at 248-582-6547 or email at sangeeta.dasadhikary@stefanini.com 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 Doing
Details:
What you'll bring
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.
Job Description
Stefanini Group is hiring!
Exciting opportunity awaits, let us help you get started!
Click Apply now or you may call Sangeeta Dasadhikary at 248-582-6547 or email at sangeeta.dasadhikary@stefanini.com 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 Doing
- Primary 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 deliverables
- Generate alternatives and take reasonable risks while solving technical problems
- Complete detailed, high quality technical documentation to capture and communicate designs
- Seek knowledge of the business, market, industry and competitive environment
- Use existing tools and best practices to report and track product and process metrics
- Inform others proactively about developments or issues that affect their work, and their ability to meet commitments
- Other duties may be assigned
Details:
What you'll bring
- Bachelor's degree in engineering
- 3 years of experience
- Ability to generate alternative solutions to problems or processes
- Strong Interpersonal skills with the ability to work collaboratively with others in a team environment
- Ability to adapt to change
- Good judgment in selection methods and techniques to acquire results
- Knowledge of Medical Device Regulations and Standards including design control and risk management is preferred
- Proficient in systems engineering tools such as DOORS, Polarion, and Minitab
- Knowledge of different subject areas making up systems including electrical, mechanical, pneumatic, software, materials, and/or wireless connectivity
- Strong technical writing and communication skills
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.
