Job Summary
The Principal Engineer, Quality will play a key role in ensuring product excellence by analyzing, developing, implementing, and executing processes that uphold the highest standards of quality. This position provides technical project support and guidance across the validation, verification, commercialization, and life-cycle management of BU-INS-IVX infusion systems and related disposable products.
Salary Range: ;Job Posting Range: $115,000-$135,000
• Position is eligible to participate in a bonus plan with a target of 10% of the base salary (include only if applicable to the grade level)
• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.
Hybrid role: Onsite 3 days per week
Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.
Responsibilities
Support the execution of quality assurance processes for medical devices in accordance with applicable industry standards and regulations, such as IEC/ISO 62304 (Medical Device Software Lifecycle), 21 CFR 820.30 (Design Controls), ISO 14971 (Medical Device Risk Management), IEC 60601 (Electrical Safety), ISO 10993 (Biological Evaluation), and IEC 62366‑1 (Usability Engineering).
Participate in software and hardware testing and validation activities to confirm products meet defined requirements and intended use.
Work with cross‑functional team members to apply established quality metrics, standards, and procedures throughout the software and product development lifecycle.
Contribute to risk assessment activities by supporting hazard identification, documentation, and risk control verification under guidance from senior team members.
Assist in the review and execution of verification test plans, test cases, and validation protocols to support confirmation that design outputs meet design inputs.
Develop working knowledge of applicable regulations, standards, and industry best practices related to medical device software and product quality.
Support internal and external audits and inspections by preparing documentation, responding to requests, and implementing assigned follow‑up actions.
Participate in investigation of reported product defects and support documentation of findings for corrective and preventive actions (CAPAs).
Communicate quality‑related topics with development and regulatory team members and escalate issues as appropriate.
Support continuous improvement activities by assisting with complaint investigations, CAPAs, and process updates.
Review design documentation and specifications for completeness, clarity, and testability under supervision.
Participate in design reviews and contribute to quality planning activities as assigned.
Assist with pre‑market and post‑market risk management activities, including documentation updates and evidence collection.
Maintain accurate records and documentation to support regulatory compliance throughout the product lifecycle
All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities
Requirements
• B.S. degree in Engineering or related field.
• 5+ years of related experience or equivalent combination of education and experience.
• Experience in compliant practices of design control and medical device risk management.
• Excellent verbal and written communication skills.
• Strong leadership and project management skills.
• Strong analytical capability and attention to detail.
• Ability to operate independently and exercise good judgment.
• Able to use electronic systems including IT equipment to carry out duties
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
