About the RoleAs a Systems Engineer based in Raleigh, NC, you'll lead product design at the system level and help ensure complex medical technology meets customer, manufacturing, service, market, safety, and regulatory requirements. You'll own system requirements and architecture, guide product integration and verification, and serve as the technical lead on the Product Ownership Team alongside Project and Product Management. The compensation range for this position is $113,900 to $148,100. Additionally, this role is on-site and includes occasional national and international travel.
This position is not eligible for current or future employment visa sponsorship.
What You'll Do- Own top-level system requirements and system architecture, translating user needs into defined and approved product requirements.
- Serve as Technical Lead on the Product Ownership Team and guide system-level design decisions throughout the development lifecycle.
- Evaluate system performance and conduct trade-off analyses involving reliability, cost, schedule, manufacturability, safety, and technical risk.
- Lead system integration and test planning, review verification plans and procedures, and confirm traceability between requirements and verification testing.
- Coordinate external system testing with Compliance Engineering and notified bodies such as TÜV and UL.
- Support system risk analysis, configuration management, Agile development activities, sustaining engineering, and documentation of system changes.
What You Bring- BS, MS, or PhD in Electrical Engineering, Physics, Electrical Computer Engineering, Computer Science, or a related field.
- 8+ years of regulated-industry experience, including 5+ years as a Systems Engineer or in a similar role.
- Experience across the product development lifecycle in a highly regulated industry.
- Solid understanding of software-design methodologies and deliverables, safety methodologies such as IEC 60601 or similar standards, and microprocessor-controlled systems.
- Broad understanding of analog and digital hardware design, with general knowledge of optical and mechanical design.
- Expert-level ability to document and communicate system engineering and design deliverables.
What Will Make You Successful- Strong analytical thinking, complex problem-solving, critical thinking, and decision-making capabilities.
- Excellent written and verbal communication, stakeholder management, collaboration, and organizational skills.
- Ability to evaluate system architectures, integration methods, performance trade-offs, technical risks, and changes in scope.
- Experience designing medical systems or similarly complex systems is preferred.
- Knowledge of medical-device quality standards and regulations, image-acquisition systems, image-processing techniques, communications networks, and complex-system testing is preferred.
- Strategic thinking, creativity, innovation, and the ability to mentor others.
Eligible Employee Benefits - Medical / Dental / Vision including a state-of-the-art wellness program and access to pet insurance, too!
- 3 weeks vacation accrual for full time roles,* paid holidays plus paid sick time too
- Up to 8 weeks of 100% paid company parental leave; includes maternal/ paternal leave, adoption, and fostering of a child.
- 401(k) retirement savings plan providing a match of 66.67% (4%) of the employee's first 6% contribution (up to IRS limits)
- Section 125 Flexible Spending Accounts
- HSA Savings Accounts with company contribution
- Life, STD & LTD Insurance
- We prepay your tuition up to $5,250 per year! - Tuition pre-imbursement
- Fitness reimbursement of up to $200 annually
- And much more!
* Field sales, internships, and roles that are regularly scheduled to work less than 30 hours per week are not eligible for vacation, except where required by law.
Non-employees, including temporary workers and consultants, are not eligible to participate in the KARL STORZ benefits program.
KARL STORZ reserves the right to change or modify the employee's job description whether orally or in writing, at any time during the employment relationship. Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor. Employees must comply will all applicable KARL STORZ policies and procedures.
Credentialing requirements at KARL STORZKARL STORZ is committed to maintaining a safe work environment for our employees and customers. Most field-based roles at KARL STORZ require hospital credentialing/health screens as a condition of employment. Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers. During the interview process, we encourage you to ask how credentialing/health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.
Pay TransparencyThe pay range and/or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future. When determining a specific team member's base salary and/or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.
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