Sr. Principal Systems Engineer (Medical Devices)

Location: Milwaukee, Wisconsin, United States; flexible workplace policy with a required minimum number of onsite days per week

Salary: $128,000–$176,000 annually, plus an annual incentive bonus

Company

Develops healthcare products and medical technologies designed to improve patient outcomes and save and sustain lives.

What you will do

• Own technical roadmaps, system architecture, design inputs, interface requirements, and product requirements for medical-device product families.
• Translate customer, market, user, and clinical needs into system requirements and workflows with marketing, clinical, program-management, and engineering stakeholders.
• Lead electrical, mechanical, and software engineering resources in requirements decomposition and resolution of cross-functional design trade-offs.
• Define verification and validation strategies, requirements traceability, usability requirements, and technical documentation for the Design History File.
• Lead medical-device risk-management activities, including hazard identification, mitigations, and residual-risk determination.
• Support product changes, CAPA activities, complaint and post-market investigations, critical issue resolution, and platform-based product designs.

Requirements

• Bachelor’s degree in mechanical, electrical, software, biomedical engineering, or a comparable technical field.
• 8+ years of engineering experience with medical devices.
• Knowledge of ISO 14971 risk management and IEC 60601 medical-device safety compliance.
• Experience applying systems-engineering principles in an Agile SAFe framework, including Epic, Feature, Story, and backlog-prioritization support.
• Fundamental understanding of hardware and software engineering, strong communication, planning, decision-making, and problem-solving skills.
• Must be authorized to work for any employer in the United States; visa sponsorship is not available.

Nice to have

• Experience with MATLAB/MBSE, Azure DevOps, Polarion, or Trackwise.
• Experience with resting ECG devices, AFE, or cardiographs.

Culture & Benefits

• Cross-functional R&D collaboration focused on healthcare products and patient care.
• Flexible workplace policy combining remote flexibility with required onsite collaboration.
• Medical and dental coverage beginning on day one, plus life, disability, and travel accident insurance.
• 401(k) plan with company matching, employee stock purchase plan, flexible spending accounts, and educational assistance.
• Paid holidays, 20–35 days of paid time off based on service length, family and medical leave, and paid parental leave.