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As part of an R&D project team, the Principal Engineer Systems/V&V provides technical contributions to the system design and Verification/Validation of a complex medical device from concept through commercialization and through the full life cycle of the product. A principal engineer focuses on understanding/defining the customer needs; creates product functional/performance requirements and architecture necessary to meet those needs; evaluates constraints and makes trade off decisions; creates system design requirements and contributes to the development of the 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 principal engineer works in close collaboration with the Lead engineer, project manager, and other functional team members to ensure the project/product success. The principal engineer provides guidance to other engineers on technical issues, engages in design reviews and help resolves complex problems. This Principal engineer will be at the forefront of driving systems engineering methodology and V&V, best practices, and continuous improvement in R&D processes and projects. This position will include using model-based design for systems engineering, Mathworks-Matlab, Simulink, System Composer, and DOORS/Polarion.
Incorporate business, market, industry and competitive knowledge into technical solutions
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
Challenge project teams and established work processes and proactively finds creative methods to reach desired performance levels
Inform others proactively about developments or issues that affect their work
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
Requirements:
Bachelor’s Degree in Engineering or related fields
5+ 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
Excellent judgment in selection methods and techniques to acquire results
Deep knowledge of Medical Device Regulations and Standards including design control and risk management is preferred
Proficient in systems engineering tools such as DOORS, Polarion, Mathworks- Matlab, Simulink, and System Composer
Knowledge of different subject areas making up sophisticated systems electrical, mechanical, pneumatic, software, materials, and/or wireless connectivity
Strong technical writing skills
What we offer:
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts
educational assistance programs
paid holidays
paid time off ranging from 20 to 35 days based on length of service