Principal Engineer (Systems, Requirements)

Job SummaryThe Principal Engineer, Infusion Systems, is a Systems Engineer with expertise developing and managing system and subsystem requirements for medical device products and collaborating with the broader R&D team to develop robust records for the Design History File. The engineer has responsibility for system-level 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, cyber security, and human factors team members to ensure that systems development is done in a holistic manner to satisfy our customers and regulatory agencies.
Salary Range: $105,000 - $115,000
• Position is eligible to participate in a bonus plan with a target of 8% 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.
This role is fully Remote
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

Develops system- and subsystem-level requirements for medical devices that include electromechanical hardware, software, disposables, and labeling.

Reviews systems engineering related processes and ensures they are current with industry standards and regulatory requirements.

Contributes to other R&D system engineering activities as needed including risk management, architecture review, V&V strategy, and post-market surveillance.

Keeps abreast of new developments in the industry and translates those developments into new and viable options for the organization and customers.

Investigates issues to determine root cause using established problem-solving tools.

Ensures that research and design methodologies meet established scientific and engineering standards.

Participates in design activities to ensure overall system performance is considered in product design decisions.

Presents technical information in a clear and precise manner.

Works independently with latitude for individual judgment. Exercises judgment within defined procedures and practices to determine appropriate action.

Requirements

• B.S. degree in Engineering or related field.
• Minimum of 5 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 to ISO 13485, ISO 14971 and IEC62304 preferred.
• 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 judgement.

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.

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.