Description

Job Overview

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, and high-quality products to market. The role also 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 Principal Systems Engineer mentors engineers and influences technical strategy across programs.

This role also assumes systemlevel product ownership for safety, performance, and compliance across the full lifecycle, including development, installed base, and postmarket use. The Principal Systems Engineer collaborates with Product Care, PostMarket Surveillance, and Field Action teams to ensure product issues are identified, assessed, and mitigated in alignment with regulatory expectations.

Job Responsibilities and Essential Duties:

 System Architecture & Requirements Leadership (40%)

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 postmarket insights.

Technical Integration & Risk Management (25%)

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 (NonConformance Reports), assessing systemlevel 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.

Verification, Validation & Regulatory Support (20%)

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 623661 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 crossfunctional data collection for complaints, investigations, PSUR inputs, and system-level risk analyses to ensure accurate evaluation and timely resolution of product issues.

Technical Mentorship & Strategic Influence (15%)

Mentor engineers, establish systems engineering best practices, and contribute to longterm 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 postmarket surveillance, field actions, risk management, engineering change processes, NCRs, and product safety evaluations.

Requirements

Minimum Requirements

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 postmarket investigations (complaints, NCRs, product concerns) and coordinating cross-functional data collection for safety and performance evaluations is strongly preferred.
 

Certifications (Preferred)

INCOSE Systems Engineering Certification (ASEP/CSEP)
Project Management or Risk Management certifications a plus
Training or certification in PostMarket Surveillance, CAPA, NCR processes, or Regulatory Compliance is desirable.

Required Knowledge, Skills, and Abilities

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 (e.g., SOLIDWORKS, Polarion, Jama, SysML tools)
Excellent analytical, documentation, and communication skills
Ability to influence without direct authority and operate effectively in a matrixed organizationStrong judgment, accountability, and attention to detail in safety-critical environments

Knowledge of postmarket surveillance processes, field action coordination, complaint trend analysis, and systemlevel safety assessments.
Familiarity with ECO/Change Control processes and ability to provide system-level technical assessments for design updates and NCR/Deviation evaluations.