Sr. Engineer, Systems - Defined Term

Getinge; Wayne (NJ); Hybrid; USD 119,000 - 125,000; Full time

Benefits offered by this job

Health insurance

401k plan with company match

Paid Time Off

Wellness initiative & Health Resources

Job summary

Getinge is seeking a Sr. Engineer, Systems - Defined Term in Wayne, NJ, hybrid role requiring 5+ years in systems engineering for electromechanical medical devices.

You will leverage JAMA for requirements management and ensure regulatory compliance (21 CFR 820.30) while leading design reviews and cross-functional collaboration. The role emphasizes maintaining the current product, driving improvements, and delivering scalable, maintainable solutions aligned with regulatory standards.

Qualifications

• BS in Systems, Biomedical, Electrical, or Software Engineering or advanced degree in lieu of experience.
• 5+ years related experience in systems engineering or equivalent.
• Strong knowledge of medical device development methodologies and regulatory requirements.

Responsibilities

• Support development and improvement of on-market electromechanical medical devices.
• Use JAMA to manage requirements and ensure traceability.
• Collaborate with cross-functional teams to define scope and deliverables.
• Participate in design reviews and provide feedback for high-quality designs.
• Maintain current product while implementing innovative solutions.

Skills

Systems engineering

Regulatory understanding

Problem solving

Team collaboration

Verbal/written communication

Education

BS in Systems Engineering

Tools

JAMA

Job description

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Sr. Engineer, Systems - Defined Term

Location: Wayne, NJ, US

Company: Datascope Corp.

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

Salary Range: Salary range: $119k - $125k

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 Sr. Systems Engineer will be responsible for providing technical input to a team of systems and cross-functional engineers. You will support the development and improvement of on-market electromechanical medical devices, ensuring that improved practices and industry standards are adhered to. A key aspect of this role involves the use of tools such as JAMA for requirements management and traceability, ensuring that all project deliverables meet the specified criteria. The ideal candidate will support implementation of changes and is capable of working with a degree of flexibility while maintaining the current product and driving improvements in our systems engineering practices. The systems engineer will ensure that development and remediation activities are compliant with internal development processes and regulatory requirements specifically 21 CFR 820.30.

Job Responsibilities and Essential Duties

• 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
• BS in Systems, Biomedical, Electrical, or Software Engineering with 5+ years related experience or advanced degree in leu of experience.

Required Knowledge, Skills and Abilities

• 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

This is a “Defined Term” assignment that will last approximately 12 months or until project is complete. Defined Term employees are eligible for most benefits (including health insurance and paid time off) while on assignment.

Salary range: $119k - $125k

About us

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 includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Benefits at Getinge:

At Getinge, we offer a comprehensive benefits package, which includes:

• 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
• Parental and Caregiver Leave
• Tuition Reimbursement

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.