Principal Engineer- Systems and 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
• 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
• Works in close collaboration with the Lead engineer, project manager, and other functional team members to ensure the project/product success
• Provides guidance to other engineers on technical issues, engages in design reviews and help resolves complex problems
• Will be at the forefront of driving systems engineering methodology and V&V, best practices, and continuous improvement in R&D processes and projects
• Will include using model-based design for systems engineering, Mathworks-Matlab, Simulink, System Composer, and DOORS/Polarion
• Identify technical problems, provides innovative, creative solutions
• shares technical knowledge with team
• Incorporate business, market, industry and competitive knowledge into technical solutions that can be readily adapted to changes in technology and/or clinical use
• 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, and their ability to meet commitments
• 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

• 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

Deep knowledge of Medical Device Regulations and Standards including design control and risk management

• 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), with the ability to purchase company stock at a discount
• 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
• Flexible Spending Accounts
• Educational assistance programs
• Paid holidays
• Paid time off ranging from 20 to 35 days based on length of service
• Family and medical leaves of absence
• Paid parental leave
• Commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• Childcare benefits