Principal Engineer, Systems - Technical Product Lead

Getinge•Wayne, NJ

1d•$150,000 - $190,000

About The Position

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. The role provides technical direction throughout product development, ensuring system-level requirements, risk management, verification, and validation meet regulatory and business objectives. It partners with cross-functional teams to deliver safe, compliant, high-quality products and aligns development with usability engineering, reliability, and post-market surveillance expectations set by the FDA and global regulatory bodies. The Principal Systems Engineer also mentors engineers and influences technical strategy across programs. The position assumes system-level product ownership for safety, performance, and compliance across the full lifecycle, including development, installed base, and post-market use. It collaborates with Product Care, Post-Market Surveillance, and Field Action teams to identify, assess, and mitigate product issues in alignment with regulatory expectations. The role leads system architecture and requirements, technical integration and risk management, verification and validation, regulatory support, and technical mentorship. It supports post-market investigations, complaints, NCRs, field actions, quality holds, CAPA, and audits, and provides system-level technical assessment of product issues and proposed changes.

Requirements

Bachelor’s degree in engineering (Systems, Biomedical, Electrical, Mechanical, Software, or related field) and 10+ years of related experience; alternatively, an MS or PhD in Systems, Mechanical, Biomedical, Electrical, or Software Engineering with 8+ years of related experience.
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 integration challenges.
Experience with requirements management and modeling tools such as SOLIDWORKS, Polarion, Jama, or SysML tools.
Excellent analytical, documentation, and communication skills.
Ability to influence without direct authority and work effectively in a matrixed organization.
Strong judgment, accountability, and attention to detail in safety-critical environments.
Knowledge of post-market surveillance processes, field action coordination, complaint trend analysis, and system-level safety assessments.
Familiarity with ECO/Change Control processes and ability to provide system-level technical assessments for design updates and NCR/deviation evaluations.

Nice To Haves

5+ years of experience in medical devices or similarly regulated industries.
Experience supporting post-market investigations, including complaints, NCRs, or product concerns, and coordinating cross-functional data collection for safety and performance evaluations.
INCOSE Systems Engineering Certification (ASEP/CSEP).
Project Management or Risk Management certifications.
Training or certification in Post-Market Surveillance, CAPA, NCR processes, or Regulatory Compliance.

Responsibilities

Define and maintain system architectures, system-level requirements, and interface definitions across hardware, software, mechanical, usability, and clinical domains, ensuring lifecycle traceability.
Collaborate with Product Care teams to keep system requirements aligned with field performance, complaint trends, and post-market insights.
Lead system integration activities and hazard analyses, and manage risks 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 and technical impact, and determining whether design or manufacturing actions may be needed.
Provide system-level approval or input for NCRs involving deviation or production-impact decisions.
Participate in investigations of product safety, performance, and compliance issues, and support risk evaluations arising from complaints, NCRs, or production trends.
Lead systems engineering strategies for verification and validation in compliance with FDA, IEC, ISO, and global regulatory standards.
Support design reviews, regulatory submissions, and audits, including human-factors validation per IEC 62366-1 and FDA human-factors guidance.
Provide system-level documentation, architecture descriptions, risk traces, and verification summaries for submissions such as 510(k), PMA, and technical files.
Support Field Actions, Quality Holds, and CAPA when system-level issues require technical coordination.
Coordinate cross-functional data collection for complaints, investigations, PSUR inputs, and system-level risk analyses to support 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 subject-matter expert during audits related to post-market surveillance, field actions, risk management, engineering change processes, NCRs, and product safety evaluations.