Principal Systems Engineer

Job title: Principal Systems Engineer

About the Role The Principal Systems Engineer is a senior technical leader responsible for defining, architecting, and integrating complex medical device systems across hardware, software, firmware, and clinical use environments. This role provides technical direction across product development lifecycle, ensuring system-level requirements, risk management, verification, and validation activities meet regulatory and business objectives. The role also mentors engineers, influences technical strategy across programs, and assumes system-level product ownership for safety, performance, and compliance across the full lifecycle, including development, installed base, and post-market use.

What You'll Do

• Define and maintain system architectures, system-level requirements, and interface definitions across hardware, software, mechanical, usability, and clinical domains; ensure traceability throughout the product lifecycle. Collaborate with Product Care teams to align with field performance, complaint trends, and post-market insights.
• Lead system integration activities, hazard analyses, and risk management in accordance with ISO 14971. Identify and resolve cross-domain technical issues and ensure alignment with regulatory expectations. Review and contribute to NCRs, assessing system-level risk, technical impact, and the need for design or manufacturing actions. Provide system-level approval or input for NCRs requiring deviation or production impact decisions. Participate in investigations of product safety, performance, and compliance issues and support risk evaluations triggered by complaints, NCRs, or production trends.
• Provide systems engineering leadership for verification and validation strategies, ensuring compliance with FDA, IEC, ISO, and global regulatory standards. Support design reviews, submissions, and audits. Support HF validation per IEC 62366‑1 and FDA human factors guidance. Contribute to regulatory submissions by providing system-level documentation, architecture descriptions, risk traces, and verification summaries. Support Field Actions, Quality Holds, and CAPA processes when system-level issues require technical coordination. Coordinate cross‑functional data collection for complaints, investigations, PSUR inputs, and system-level risk analyses to ensure accurate evaluation and timely resolution of product issues.
• Mentor engineers, establish systems engineering best practices, and contribute to long‑term technical roadmaps and platform strategies. Serve as a subject matter expert for Design Controls and systems engineering processes, guiding teams during audits and regulatory inspections. Act as a technical SME during audits related to post‑market surveillance, field actions, risk management, engineering change processes, NCRs, and product safety evaluations.

What We're Looking For

• Bachelor’s degree in engineering (Systems, Biomedical, Electrical, Mechanical, Software, or related field) with 10+ years of related experience. MS or PhD in Systems, Mechanical, Biomedical, Electrical, or Software Engineering with 8+ years of related experience. 5+ years in medical devices or similarly regulated industries preferred.
• Experience supporting post‑market investigations (complaints, NCRs, product concerns) and coordinating cross-functional data collection for safety and performance evaluations strongly preferred.
• Certifications (Preferred): INCOSE Systems Engineering Certification (ASEP/CSEP). Project Management or Risk Management certifications a plus. Training or certification in Post‑Market Surveillance, CAPA, NCR processes, or Regulatory Compliance is desirable.
• Required knowledge, skills, and abilities include: deep knowledge of systems engineering methodologies, requirements management, and system architecture development; strong understanding of FDA Design Controls, ISO 13485, IEC 62304, IEC 60601, ISO 14971, and usability engineering principles; ability to lead cross-functional technical teams and resolve complex integration challenges; experience with requirements management and modeling tools; excellent analytical, documentation, and communication skills; ability to influence without direct authority in a matrixed organization; strong judgment, accountability, and attention to safety-critical environments; knowledge of post‑market surveillance processes, field action coordination, complaint trend analysis, and system‑level safety assessments.

Nice to Have

• INCOSE Systems Engineering Certification (ASEP/CSEP) and training in Post‑Market Surveillance, CAPA, NCR processes, or Regulatory Compliance is desirable.
• Additional certifications in Project Management or Risk Management.

Compensation & Benefits

• Salary range: $150,000 – $180,000 per year with a 15% bonus potential. Hybrid remote work arrangement: 1-2 days at home and on-site as needed.
• Location: United States; remote/hybrid work setup described above.
• Benefits details are not specified in the posting.