Principal Engineer, Systems - Technical Product Lead
Getinge
Summary
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.
Job 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.
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.
Requirements
- Bachelor's degree in engineering (Systems, Biomedical, Electrical, Mechanical, Software, or related field) 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 post-market investigations (complaints, NCRs, product concerns) and coordinating cross-functional data collection for safety and performance evaluations strongly preferred
- INCOSE Systems Engineering Certification (ASEP/CSEP) preferred
- Project Management or Risk Management certifications a plus
- Training or certification in Post-Market Surveillance, CAPA, NCR processes, or Regulatory Compliance desirable
- 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
- 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
Benefits
- Health, Dental & Vision Insurance
- 401(k) Matching
- Paid Time Off
- Wellness Initiative
- Health Assistance Resources
- Life Insurance
- Short & Long Term Disability
- Flexible Spending Accounts
- Commuter Benefits
- Parental & Caregiver Leave
- Tuition Reimbursement
Company overview
Getinge AB is a leading Swedish medical technology company founded in 1904 and headquartered in Gothenburg, Sweden. As a publicly traded company listed on Nasdaq Stockholm, Getinge specializes in developing and manufacturing advanced medical devices and solutions for healthcare and life sciences industries. The company operates through three core business areas: Life Science, Acute Care Therapies, and Surgical Workflows. Getinge's comprehensive product portfolio includes ventilators, heart-lung machines, anesthesia systems, surgical tables, sterilizers, washer-disinfectors, bioreactors, and digital health solutions. With approximately 12,000 employees worldwide, operations in 40 countries, and sales in over 135 countries, Getinge has established itself as a global leader in medical technology. The company maintains manufacturing facilities across Europe, Asia, and North America, with the United States representing its largest market. Getinge's commitment to innovation and patient safety has made it a trusted partner for hospitals, research laboratories, and pharmaceutical production facilities worldwide, dedicated to improving clinical outcomes and optimizing healthcare workflows.