Getinge · 1 day ago
Sr. Engineer, Systems - Defined Term
Wayne, NJ
Full-time
Onsite
Senior Level
$115K/yr - $125K/yr
5+ years expGetinge is dedicated to making life-saving technology accessible for more people, and they are seeking a Senior Systems Engineer to join their team. The role involves providing technical input for the development and improvement of electromechanical medical devices while ensuring compliance with regulatory requirements and industry standards.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Support the development and improvement of on-market electromechanical medical devices, ensuring that solutions are scalable, maintainable, and meet regulatory requirements
Utilize tools such as JAMA to manage requirements, track progress, and ensure traceability throughout the project
Collaborate with cross-functional teams to define project scope, objectives, and deliverables
Participate in design reviews and provide constructive feedback to team members to ensure high-quality designs
Maintain the current product while implementing innovative solutions and improvements
Support the development and remediation of electromechanical medical devices, ensuring that solutions are scalable, maintainable, and meet regulatory requirements
Utilize tools such as JAMA to manage requirements, risk, track progress, and ensure traceability throughout the project
Collaborate with cross-functional teams to define project scope, objectives, and deliverables
Participate in design reviews and provide constructive feedback to team members to ensure high-quality designs
Maintain the current product while implementing innovative solutions and improvements
Drive product improvements based on data and feedback
Ensure compliance with all relevant regulatory requirements and standards
Qualification
Required
BS in Systems, Biomedical, Electrical, or Software Engineering with 5+ years of related experience
MS or PhD in Systems, Biomedical, Electrical, or Software Engineering with 3+ years of related experience
Strong track record of supporting the development of electromechanical medical devices
Proficiency in using tools such as JAMA for requirements management and traceability
Strong understanding of medical device development methodologies and regulatory requirements
Excellent problem-solving skills and the ability to think critically and strategically
Strong communication and interpersonal skills, with the ability to effectively collaborate with team members and stakeholders
Participate in technical meetings with cross-functional team members
Knowledge of requirements development, traceability, and allocation
Knowledge of medical device risk management, including ISO 14971:2012; Knowledge of ISO 13485:2016
Knowledge of design verification and validation concepts, including the planning and execution of system-level testing of medical devices
Medical Device experience including thorough understanding of Design Controls (21 CFR 820.30)
Working knowledge of FDA and International Standards requirements as related to capital equipment
Experience with Requirements Management Tools (such as JAMA)
Strong organizational and technical writing skills
Excellent written and verbal communication skills
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
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