Principal Engineer, Systems - Technical Product Lead

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.

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 system‑level product ownership for safety, performance, and compliance across the full lifecycle, including development, installed base, and post‑market use. The Principal Systems Engineer collaborates with Product Care, Post‑Market 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 post‑market 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 (Non‑Conformance Reports), 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 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 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 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 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 SME during audits related to post‑market surveillance, field actions, risk management, engineering change processes, NCRs, and product safety evaluations.

Minimum Requirements

* Bachelor's…