Staff Digital Systems Engineer

Smith+Nephew; Andover (MN); Hybrid; USD 145,000 - 218,000; Full time

Benefits offered by this job

401k Matching Program

Tuition Reimbursement

Health, Dental, Vision

Hybrid Work Model

Paid Holidays

Job summary

Smith+ Nephew is seeking a Staff Digital Systems Engineer in Andover, MA on a hybrid schedule. You will lead end-to-end system design for connected medical devices spanning hardware, firmware, apps, cloud services, and data platforms, turning user needs into testable requirements.

You will collaborate with software, cloud and cybersecurity teams to define interfaces and non-functional requirements, support verification, risk management and regulatory documentation for regulated medical products.

Qualifications

• Experience delivering complex medical device or regulated products.
• Strong systems engineering and requirements management.
• Knowledge of medical device regulations and standards.
• Experience with cloud platforms and data interfaces.
• Ability to lead cross-disciplines and communicate clearly.

Responsibilities

• Lead end-to-end system design for connected medical devices across hardware, firmware, apps, cloud services and data platforms.
• Translate user needs into clear, testable system requirements and architectures.
• Own system requirements development, including user needs and interface specs.
• Define cloud-connected system interfaces, data flows and interoperability requirements.
• Partner with software, cloud and cybersecurity teams to specify non-functional requirements (availability, security).
• Drive cybersecurity and privacy engineering activities and regulatory documentation.
• Develop system verification and validation strategies for regulated medical systems.
• Support system integration, risk management and cross-functional issue resolution.

Skills

Systems engineering

Requirements management

System architecture

Design controls

Regulatory knowledge (IEC 62304, ISO

Education

B.S. in Computer Science / Computer Engineering / Electrical Engineering

M.S. preferred

Tools

AWS

Azure

GCP

Job description

Staff Digital Systems Engineer (Andover, MA - Hybrid)

Life. Unlimited. At Smith+ Nephew we design and manufacture technology that takes the limits off living.

Are you ready to lead the design of next generation connected medical systems that truly make a difference? As a Staff Digital Systems Engineer within our Advanced Wound Management R&D team, you will play a pivotal role in shaping cloud connected, wearable and digital health solutions from early concept through launch. This is a highly visible technical leadership role where your expertise will directly impact patient outcomes and the future of digitally enabled care.

What will you be doing?

• Leading end to end system level design for connected medical devices, spanning device hardware, firmware, mobile applications, cloud services and data platforms
• Translating user needs and stakeholder inputs into clear, testable system requirements and architectures
• Owning system requirements development, including user needs, design inputs and interface specifications
• Defining cloud connected system interfaces, data flows, APIs and interoperability requirements
• Partnering with software, cloud and cybersecurity teams to define non functional requirements such as availability, scalability, security and privacy
• Driving cybersecurity and privacy engineering activities including threat modeling, security requirements and regulatory documentation
• Developing system verification and validation strategies for complex, regulated medical systems
• Supporting system integration, risk management activities and issue resolution across cross functional teams
• Contributing to pre clinical and clinical evaluations through protocol input and technical troubleshooting as needed

What will you need to be successful?

• A B.S. in Computer Science, Computer Engineering, Electrical Engineering or a related technical field, with an M.S. preferred
• 6+ years of related experience with a B.S.
• 3+ years of related experience with an M.S.
• Significant experience delivering complex medical device or regulated products, including connected or cloud enabled systems
• Strong systems engineering expertise, including requirements management, system architecture and design controls
• In depth knowledge of medical device regulations and standards such as IEC 62304, ISO 14971, IEC 60601 and FDA or EU MDR
• Experience with cloud platforms such as AWS, Azure or GCP, including security, networking and data considerations
• The ability to lead technically across disciplines, communicate clearly and drive outcomes in a collaborative environment

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 Purchase Plan, 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
• Flexibility: Hybrid Work Model (For most professional roles)
• Training: Hands-On, Team-Customized, Mentorship
• Extra Perks: Discounts on fitness clubs, travel and more!

The anticipated base compensation range for this position is $145,250 - $217,750 USD annually. The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, geographical location, and internal equity. It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew. Compensation decisions are dependent upon the facts and circumstances of each position and candidate. In addition to base pay, we provide competitive bonus and benefits, which include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, parental leave, and generous PTO, paid company holidays annually and 8 hours of Volunteer time and a variety of wellness offerings such as EAP.

Smith+ Nephew 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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