Stefanini Group is hiring!
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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
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
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