Senior Systems Engineer

Description

Job Title

As a Systems Engineer, you will provide technical leadership for capital equipment development, translating clinical, customer, business, and regulatory needs into system solutions. You will lead system design and drive cross-functional project execution, ensuring alignment across requirements, architecture, risk management, verification, and delivery.

Responsibilities

• Lead system design and architecture for projects, including requirements development, interface definition, design decisions, and technical trade-offs.
• Translate clinical workflows, user needs, and regulatory requirements into clear, testable system requirements while maintaining end-to-end design traceability.
• Assess and maintain Design History Files (DHF) and Design and Development Files (DDF), ensuring compliance with design controls, documentation standards, and regulatory requirements.
• Drive system risk management, verification and validation planning, design reviews, and change-control activities in collaboration with cross-functional teams.
• Manage project scope, schedules, resources, risks, and dependencies while leading technical discussions, resolving issues, and communicating progress to stakeholders.
• You're the right fit if:
• Bachelor's or Master's degree in Systems, Biomedical, Electrical, Mechanical, Software Engineering, or a related discipline, with 5+ years of experience in systems engineering, product development, or technical project leadership within medical devices or another regulated industry.
• Strong experience in systems engineering, including system architecture, requirements development, interface definition, verification planning, and requirements traceability.
• Working knowledge of medical device design controls, risk management, and verification and validation, including familiarity with ISO 14971 and IEC 60601 standards.
• Demonstrated ability to lead complex, cross-functional technical projects, manage competing priorities, resolve issues, and influence stakeholders without direct authority.
• Experience with engineering and project management tools such as DOORS, DNG, Windchill, Jira, or equivalent platforms, along with strong communication and technical documentation skills.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position .

Conditions

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an office role.

About the company

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

Learn more about our business .

Discover our rich and exciting history.

Learn more about our purpose.

Learn more about our culture.

The company Transparency Details

The pay range for this position in San Diego, CA is $115,000 to $182,000.00.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive the company Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here .

At the company, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

Additional Information

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to San Diego, CA.

LI-PH1

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

The company is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.