Principal Engineer, Systems

Getinge•Wayne, NJ

11d•$150,000 - $180,000

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. 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.

Requirements

Bachelor’s degree in engineering (Systems, Biomedical, Electrical, Mechanical, Software, or related field) required. Master’s degree preferred
10+ years of experience in systems engineering or product development, including complex, regulated products
5+ years in medical devices or similarly regulated industries preferred
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 organization
Strong judgment, accountability, and attention to detail in safety-critical environments

Nice To Haves

INCOSE Systems Engineering Certification (ASEP/CSEP)
Project Management or Risk Management certifications a plus

Responsibilities

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.
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.
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 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.
Technical Mentorship & Strategic Influence (15%): 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.