Principal Systems Engineer, R&D

Getinge
life insurance, vision insurance, paid time off, long term disability, tuition reimbursement, 401(k)
United States, New Jersey, Wayne
45 Barbour Pond Road (Show on map)
Aug 27, 2025
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 will be responsible for providing technical leadership to a team of systems and cross-functional engineers. You will guide the team in 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 be a change agent, 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 Oversee 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 traceabilitythroughout the project. Collaborate with cross-functional teams to define project scope, objectives, and deliverables. Conduct 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 analysis and feedback. Stay up-to-date and mentor a team of engineers, providing technical guidance and supportthroughout the project lifecycle. Oversee 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. Conduct design reviews and provide constructive feedback to team members to ensure high-quality designs. Act as a change agent, driving improvements in our systems engineering discipline and fostering a culture of continuous improvement. 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. Minimum Requirements BS in Systems, Biomedical, Electrical, or Software Engineering with 10+ years of related experience MS or PhD in Systems, Biomedical, Electrical, or Software Engineering with 7+ years of related experience Required Knowledge, Skills, and Abilities BS in Systems, Biomedical, Electrical, or Software Engineering with 10+ years of related experience MS or PhD in Systems, Biomedical, Electrical, or Software Engineering with 7+ years of related experience Proven experience in a technical leadership role, with a strong track record of successfully leading engineering teams in 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. Demonstrated ability to act as a change agent, driving improvements and fostering a culture of continuous improvement. Lead and manage 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 Salary range: $145,000 - $165,000K Annually / 15% Bonus #LI-LG1 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 Commuter Benefits 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.