Principal Engineer, Systems

Principal Engineer, Systems

Date:
Jan 19, 2026

Location:

Wayne, NJ, US;
Pleasanton, CA, US

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

Salary Range: $ - $

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life‑saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

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.

• 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.
• 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.
• Project Management or Risk Management certifications a plus.

• 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.

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering…