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Title: Senior Systems Engineer - Hybrid
Mandatory skills:
Contact Details :
Account co-ordinator: Godwin D Antony Raj
VIVA USA INC.
3601 Algonquin Road, Suite 425
Rolling Meadows, IL 60008
Title: Senior Systems Engineer - Hybrid
Mandatory skills:
- system design, Verification/Validation,
- Medical Device Regulations, Medical Device Standards, design control, risk management,
- systems engineering tools, DOORS, Polarion, Minitab,
- electrical, mechanical, pneumatic, software, materials, wireless connectivity,
- technical writing, technical documentation,
- product system requirements, product system architecture, product safety, security risk management, product portfolio, product development,
- verification plans, validation plans, protocols, scripts, execution, regression, reports, V&V engineering deliverables,
- business, market, industry, competitive environment
- 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.
- 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
- 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 takes reasonable risks while solving technical problems
- 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
- Hybrid
Contact Details :
Account co-ordinator: Godwin D Antony Raj
VIVA USA INC.
3601 Algonquin Road, Suite 425
Rolling Meadows, IL 60008