Stefanini Group

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 [email protected] 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 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