Principal Engineer, Systems - Technical Product Lead

Principal Engineer, Systems - Technical Product Lead

Location:

Wayne, NJ, US

Remote Work: 1-2 days at home (site based)

Salary: $150k - $180k; 15% bonus

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 phases, ensuring system‑level requirements, risk management, verification, and validation activities meet regulatory and business objectives. The position partners closely with cross‑functional teams to deliver safe, compliant, high‑quality products to market and ensures alignment with usability engineering, reliability, and post‑market surveillance expectations for medical devices as outlined by FDA and global regulatory bodies.

As a subject‑matter expert, the engineer mentors other engineers and influences technical strategy across programs.

• 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 ensure system requirements remain aligned 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 Non‑Conformance Reports (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; 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 (e.g., 510(k), PMA, technical files) 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.
• Mentor engineers; establish systems engineering best practices; contribute to long‑term technical roadmaps and platform strategies; serve as a subject‑matter expert for Design Controls and systems engineering processes; guide teams during audits and regulatory inspections.

• Bachelor’s degree in engineering (Systems, Biomedical, Electrical, Mechanical, Software, or related field) required 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 is strongly preferred.

INCOSE Systems Engineering Certification (ASEP/CSEP);
Project Management or Risk Management certifications are a plus; training or certification in Post‑Market Surveillance, CAPA, NCR processes, or Regulatory Compliance is desirable.

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; proven ability to lead cross‑functional technical teams and resolve complex…