Principal Engineer

Fresenius Kabi • North Andover, MA

3d • Hybrid

About The Position

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.

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

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

Benefits

• 401(k) plan with company contributions
• paid vacation
• holiday and personal days
• employee assistance program
• health benefits to include medical, prescription drug, dental and vision coverage
• life insurance
• disability
• wellness program

What This Job Offers

• Job Type: Full-time
• Career Level: Principal