Principal Systems Engineer
Listed on 2026-04-28
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Engineering
Systems Engineer, Biomedical Engineer
Job Overview
Principal Systems Engineer – responsible for leading and coordinating system engineering activities on complex medical devices to meet customer needs and regulatory standards.
Responsibilities- Lead development of Design Inputs and Digital Interface Requirements.
- Work with cross‑functional team members (Marketing, Clinical) to translate user needs into system requirements.
- Lead engineering resources (Electrical, Mechanical, Software) in decomposing system requirements into derived requirements.
- Resolve competing constraints among inter‑related functions (engineering, manufacturing, regulatory, marketing) to deliver products to market.
- Resolve interface issues and document theory of operations for complex medical product designs.
- Collaborate with verification engineers to define test strategies and develop verification/validation plans with requirement tracing.
- Support risk analysis from hazard capture through mitigation, including quantitative residual risk calculation for the Safety Assurance Case.
- Implement configuration management across the entire product life cycle.
- Interface with Manufacturing, Service, Product Surveillance, Supply Chain, and Customer Training staff during the design transfer process.
- Ensure compliance with product development process and Quality System requirements.
- Bachelor’s degree with 5+ years of experience OR Master’s degree with 3+ years of experience.
- Solid understanding of systems engineering principles and related disciplines (electro/mechanical, digital interface, fluid mechanics, materials science).
- Demonstrated success in delivering results on technical challenges with investigative and problem‑solving skills (DFSS/DMAIC/CAPA).
- Prior medical device experience preferred; infusion pumps and syringe pumps experience is a plus.
- Strong communication skills, both oral and written.
- Competitive pay range: $112,000 to $154,000 annually.
- Medical and dental coverage from day one.
- Life, accident, short‑term & long‑term disability, and business travel insurance.
- 401(k) retirement plan with company matching.
- Employee Stock Purchase Plan (ESPP).
- Flexible Spending Accounts and educational assistance.
- Paid holidays, paid time off (20–35 days based on service), family and medical leave, paid parental leave.
Baxter is an equal‑opportunity employer. Qualified applicants are evaluated without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity, protected veteran status, disability status or any other legally protected characteristic.
Reasonable AccommodationsBaxter provides reasonable accommodations for individuals with disabilities. If you require an accommodation during the application or interview process, contact recruiters with your request.
Work AuthorizationApplicants must be authorized to work in the U.S. and are not eligible for visa sponsorship at this time.
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