Sr Principal Engineer; Systems-Risk

Overview

Senior Principal Engineer, Infusion Systems, is a Systems Engineer responsible for managing product risk documentation for medical device products and collaborating with the broader R&D team to develop robust records for the Design History File. The engineer handles risk assessments and documentation for the Ivenix Infusion System during the product development process and throughout the product lifecycle. This role works cross-functionally with engineering, test, quality, manufacturing, regulatory, clinical, and human factors teams to ensure appropriate risk identification, mitigation, and documentation of activities.

Salary Range: $145,000 - $160,000

Position is eligible to participate in a bonus plan with a target of 10% of base salary (include only if applicable to the grade level). Final pay determinations will depend on experience, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive to support healthy lives and provide help when it matters most, including a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits (medical, prescription, dental, and vision).

Hybrid role, 3 days per week in North Andover.

Applicants must be authorized to work in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa now or in the future.

• Leads the development and revision of all product risk documentation per current industry standards and regulatory requirements.
• Collaborates with cross-functional team members to build Use and Design FMEAs and Risk Assessments.
• Identifies, and verifies the effectiveness of, risk control measures throughout the product lifecycle.
• Reviews Process FMEAs developed by contract and internal manufacturing teams.
• Investigates issues to determine root cause using established problem-solving tools.
• Leads Risk Management Committee meetings as appropriate, preparing information to be presented and capturing and tracking action items to closure.
• Drives compliance with internal risk processes and creates or refines tools and templates to ensure compliance per ISO 14971 and other standards and regulations.
• Develops and updates the Safety Assurance Case in collaboration with Clinical Product Specialist, Human Factors Engineering and Regulatory Affairs.
• Contributes to other R&D system engineering activities as needed including requirements management, architecture review, V&V strategy, and post-market surveillance.
• Provides training as needed when significant changes are made to risk processes.
• Participates in design activities to ensure risk reduction is considered in product design decisions.
• Contributes to risk strategies for new product feature development.
• Participates in Usability Engineering activities.
• Works independently with latitude for individual judgment and exercises judgment within defined procedures and practices to determine appropriate action.

All employees are responsible for ensuring compliance with company documents, programs and activities related to Health, Safety, Environment, Energy, and Quality Management Systems, as per roles and responsibilities.

• B.S. degree in Computer Science or related field.
• 8+ years of related experience or equivalent combination of education and experience.
• Experience with product development within a regulated industry; development of FDA-governed medical devices compliant with ISO 13485, ISO 14971, and IEC 62304 preferred.
• Experience with conducting and presenting risk analyses.
• A solid understanding of theories and practices utilized by other disciplines outside of primary area of expertise.
• Strong verbal and written communications skills.
• Ability to operate independently and exercise good judgment.

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.

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.