Systems Engineer I

Smith+Nephew; Pittsburgh (Allegheny County); On-site; USD 70,000 - 90,000; Full time

Job summary

Smith+Nephew in Pittsburgh is seeking a Systems Engineer to translate real clinical needs into innovative, high impact medical device solutions. You will collaborate with cross functional teams to design and deliver products that improve patient outcomes and drive meaningful change in healthcare.

The role emphasizes requirements management, system architecture, verification and validation, and compliance with design controls in a regulated environment.

Qualifications

• Bachelor’s degree in Biomedical, Electrical, Mechanical, Computer Engineering, or a related scientific field.
• 0-2 years experience in systems engineering and requirements management with a bachelor’s degree, or 1 year with a master’s degree
• Understanding of design control within a regulated medical device environment
• Experience or exposure to hardware software systems and requirements management tools such as DOORS, JAMA, or similar
• Strong collaboration skills with the ability to work effectively in a matrixed environment
• Excellent communication skills with the ability to engage stakeholders at multiple levels
• Self-motivated, driven, and eager to make a meaningful impact

Responsibilities

• Translate customer and clinical needs into clear, actionable product requirements and system architectures
• Lead requirements management activities, ensuring traceability from requirements through to verification and validation
• Collaborate with cross functional teams across engineering, marketing, and clinical functions to drive technical excellence
• Contribute to system architecture and design decisions that balance clinical benefit with technical feasibility
• Support verification and validation planning and participate in design validation activities
• Assist with pre-clinical and clinical evaluations to ensure product effectiveness and safety
• Continuously develop your systems engineering expertise and contribute to process improvements within the organization

Skills

Requirements management

Systems engineering

Cross-functional collaboration

Communication

Self-motivation

Education

Bachelor's degree in Biomedical, Electrical, Mechanical, or Computer Engineering

Tools

DOORS

JAMA

Job description

Life Unlimited. At Smith+Ne Are you ready to shape the future of medical technology? As a Systems Engineer at Smith+Ne, you will play a critical role in translating real clinical needs into innovative, high impact solutions. Based in Pittsburgh, you will collaborate with cross functional teams to design and deliver products that improve patient outcomes and drive meaningful change in healthcare.What will you be doing?

• Translate customer and clinical needs into clear, actionable product requirements and system architectures
• Lead requirements management activities, ensuring traceability from requirements through to verification and validation
• Collaborate with cross functional teams across engineering, marketing, and clinical functions to drive technical excellence
• Contribute to system architecture and design decisions that balance clinical benefit with technical feasibility
• Support verification and validation planning and participate in design validation activities
• Assist with pre-clinical and clinical evaluations to ensure product effectiveness and safety
• Continuously develop your systems engineering expertise and contribute to process improvements within the organization

What will you need to be successful?

• Bachelor’s degree in Biomedical, Electrical, Mechanical, Computer Engineering, or a related scientific field
• 0-2 years experience in systems engineering and requirements management with a bachelor’s degree, or 1 year with a master’s degree
• Understanding of design control within a regulated medical device environment
• Experience or exposure to hardware software systems and requirements management tools such as DOORS, JAMA, or similar
• Strong collaboration skills with the ability to work effectively in a matrixed environment
• Excellent communication skills with the ability to engage stakeholders at multiple levels
• Self-motivated, driven, and eager to make a meaningful impact

This position does not offer visa sponsorship now or in the future
You Unlimited.
We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

• Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).
• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
• Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
• Training: Hands-On, Team-Customized, Mentorship
• Extra Perks: Discounts on fitness clubs, travel and more!

Smith+Ne provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.
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