Overview
On Site
Full Time
Skills
Systems Design
System Requirements
Level Design
FMEA
Verification And Validation
Scripting
Regression Analysis
Collaboration
Design Review
FOCUS
Product Development
Reporting
Technical Writing
Communication
Management
Medical Devices
Design Controls
Risk Management
Electromechanics
Systems Engineering
IBM Rational DOORS
Minitab
Research and Development
Job Details
Responsibilities:
- Your Role at Client This is where your work saves lives 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.
- Primary focus of the 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 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.
- Bachelor's degree in engineering.
- 5 years of experience.
- Strong technical writing and communication skills.
- Ability to work collaboratively in a team environment.
- Able to manage time/work assignments to ensure deliverables are met.
- Knowledge of medical device regulations and standards, including design control and risk management.
- Systems engineering experience / electromechanical test experience.
- Use of systems engineering tools such as DOORS, Polarion, Minitab.
- Preference for at least 1-2 years minimum experience, med device R&D or other regulated industry would be ideal.
- Ability to generate alternative solutions to problems or processes.
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