Getinge · 16 hours ago
Principal Engineer, Systems
Wayne, NJ
Full-time
Onsite
Senior Level, Lead/Staff
$150K/yr - $180K/yr
10+ years expGetinge is a company dedicated to making life-saving technology accessible for more people. The Principal Systems Engineer is a senior technical leader responsible for defining, architecting, and integrating complex medical device systems, ensuring compliance with regulatory and business objectives while mentoring engineers and influencing technical strategy.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
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
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
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
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
Qualification
Required
Bachelor's degree in engineering (Systems, Biomedical, Electrical, Mechanical, Software, or related field) required
10+ years of experience in systems engineering or product development, including complex, regulated products
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
Preferred
Master's degree preferred
5+ years in medical devices or similarly regulated industries preferred
INCOSE Systems Engineering Certification (ASEP/CSEP)
Project Management or Risk Management certifications a plus
Benefits
Health, Dental, and Vision insurance benefits
401k plan with company match
Paid Time Off
Wellness initiative & Health Assistance Resources
Life Insurance
Short and Long Term Disability Benefits
Health and Dependent Care Flexible Spending Accounts
Commuter Benefits
Parental and Caregiver Leave
Tuition Reimbursement
Company
Getinge
Getinge identifies customer issues and promotes clinical and economic benefits and follow and support the customer decision process.
10001+ employees
H1B Sponsorship
Getinge has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
2023 (2)
2022 (2)
2021 (2)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$539.31M2017-10-19Post Ipo Equity· $539.31M
2002-06-28IPO
Leadership Team
C
Christoffer Å.
Chief Information Security Officer
Joanna Engelke
EVP Quality Compliance, Regulatory, Medical
Recent News
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