Sr. Principal Systems Engineer
LOCATION: San Diego, CA
HIRE TYPE: Full-time, Exempt
Job Summary
Atrial fibrillation is chaotic, patient-specific, and constantly evolving. Drugs and ablation have advanced the field — but millions of patients remain inadequately served, and the underlying electrical disorder often goes uncontrolled. MaxWell Biomedical is on a mission to develop and deploy first-of-its-kind, non-destructive technologies that restore atrial synchrony, terminate atrial fibrillation, and improve hemodynamics in patients with cardiac rhythm disorders.
We don’t merely innovate at MaxWell, we advance. We carry responsibility with courage, not caution, because the status quo resists transformation because lives are on the line, and we are here for such a time as this. Join us as we create a fundamentally new therapeutic pathway for patients who remain inadequately served by existing AF treatments—and help shape the future of cardiac rhythm management.
We are looking for a Sr. Principal Systems Engineer to serve as a senior technical authority within the R&D department, providing expert-level leadership across all phases of systems development. This individual defines and owns system architecture, requirements management, and integration strategies for complex, multi-disciplinary platforms—spanning mechanical, electrical, firmware, and software subsystems. The Sr. Principal Systems Engineer acts as a key technical resource for program teams, regulatory submissions, and executive stakeholders.
What You’ll Do
Develop, maintain, and manage system requirements (user needs, system requirements, subsystem requirements) in compliance with 21 CFR Part 820 Design Controls and ISO 13485.
Lead functional decomposition and requirements traceability throughout the full product development lifecycle from concept through design transfer.
Perform and lead system integration activities; define interface control documents (ICDs), system integration plans, and integration test strategies.
Lead system-level risk management activities in compliance with ISO 14971, including hazard identification, risk estimation, and risk control implementation.
Author and review key Design History File (DHF) documents including system specifications, design input/output documents, verification and validation protocols and reports.
Provide technical leadership and mentorship to junior and mid-level systems and design engineers; establish engineering best practices.
Drive resolution of complex, cross-disciplinary technical issues through root cause analysis, trade-off studies, and design of experiments (DOE).
Support design reviews (PDR, CDR, and peer reviews) and provide substantive technical critique across subsystem disciplines.
Evaluate and influence selection of components, platforms, and suppliers from a systems-level perspective.
Additional responsibilities may be assigned by management as needed to support evolving business priorities.
What We’re Looking For
Bachelor’s degree in systems engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a closely related discipline; master’s degree strongly preferred.
Minimum of 12 years of total engineering experience, with at least 8 years in a systems engineering role within the medical device or other safety-critical regulated industry (aerospace, defense, or nuclear).
Expert-level knowledge of IEC 60601, FDA 21 CFR Part 820, ISO 13485, ISO 14971, and IEC 62304 (software lifecycle for medical devices).
Demonstrated ability to develop and manage complex requirements hierarchies and requirements traceability matrices.
Proven ability to independently lead technical workstreams and present to senior leadership and regulatory bodies. Good teamwork and interpersonal skills.
Ability to work well independently or within a cross-functional team environment.
Excellent organizational, computing and verbal/written communication skills.
Physical Requirements
The physical demands listed below must be met to perform the essential functions of this job successfully. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Ability to work at a desk or computer workstation for extended periods of time
Must be able to comply with company safety, quality, and regulatory procedures
Occasionally required to lift/move up to 25 pounds
Ability to operate standard office equipment (computer, phone, printer) and laboratory instruments.
Vision adequate to review engineering documentation, schematics, and computer screens.
Ability to travel domestically and internationally up to 10% of the time
What We offer
MaxWell offers a total rewards package that reflects our stage, mission and commitment to investing in our people.
Opportunity to share a transformative AF therapy device from inception
Medical, Dental and Vision coverage, with MaxWell covering 60% of the cost for you and your dependents
Market-competitive compensation, including an employee stock purchase plan
Collaborative, fun, and mission-driven environment
Monthly company-sponsored lunches
How To Apply
Please send your resume and a brief letter describing your interest in this role to talent@maxwellbiomed.com. Resumes and personal information submitted to MaxWell Biomedical are used solely for recruitment purposes and will be handled in accordance with applicable privacy law. We do not share your information with third parties without your consent.
Recruitment Fraud Warning
MaxWell Biomedical will never request payment, financial information, or gift cards at any stage of the recruitment process. All legitimate communication will come from @maxwellbiomed.com email addresses. We do not extend offers via text message or unofficial platforms. If you receive suspicious outreach claiming to be from us, do not engage and report it to scams@maxwellbiomed.com.
Equal Opportunity Employer
MaxWell Biomedical is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, sex, national origin, age, disability, genetic information, veteran status, sexual orientation, gender identity, or any other protected characteristics. We welcome candidates from all backgrounds.