Principal/Senior Systems Engineer

Job Title

Requisition

Location

Additional Locations

Job Description Summary

The Principal Systems Engineer will lead system definition / development activities in one or more medical device development projects, and act as a contributor to other projects.

Job Description

Essential Functions:

• Understands the user needs, intent, constraints and value proposition of projects throughout their lifecycle. Aligns system engineering activities to meet these.

• Acquires expertise in existing device performance and behaviour to guide lifecycle management and new technology development projects.

• Acquires deep understanding of user / stakeholder needs (from multiple sources) to guide project definition.

• Creates system-level design input requirements to define overall device behaviour using best-practice approaches.

• Creates and assesses system architecture options with cross-functional (electrical / mechanical / SW) team to define optimal system solutions. Conceptualizes complete solutions.

• Decompose system requirements to subsystem requirements (including SW), ensuring functional coverage.

• Assesses technical challenges using a systems engineering mindset. Uses recognised problem-solving techniques to arrive at data-driven solutions.

• Acts as the system owner / SME, takes responsibility for system-impacting decisions.

• Supports Regulatory and Quality activities related to medical devices.

• Executes work under Keenova’s design controls process and in compliance with the company’s quality management system. Proactively improves product quality through their project work.

• Works with program managers to help create project schedules. Leads and facilitates architectural and design decisions to ensure on-time delivery of projects. Escalates technical issues in a timely manner to Systems Engineering leadership.

• Works with multiple internal stakeholder groups (Verification, Validation, Quality, Commercial, Clinical, Regulatory Affairs etc.) to resolve system definition challenges.

• Assesses and clearly communicates technical status of projects.

• Proactively identifies product improvement / innovation opportunities.

Education / Experience / Skills:

• BS degree (or above) in a scientific or engineering discipline.

• 8+ years’ Systems Engineering experience in complex Electrical/Mechanical products, preferably in a systems lead role.

• 5+ years’ medical device development experience.

• Demonstrated development experience using key medical device standards (e.g., ISO 13485, ISO 14971, IEC 60601) and regulations.

• INCOSE certification and/or demonstrated knowledge of Systems Engineering best-practices is a distinct advantage.

• Familiarity with Systems Engineering tools (e.g., Jama Connect) preferable.

• Facilitation and presentation skills: Strong ability to engage and influence diverse stakeholder groups, both technical and non-technical.

• Communication and interpersonal skills: Excellent verbal and written communication, with proven ability to communicate effectively across cross-functional teams and to senior leadership.

• Organisation and time management: Strong ability to manage multiple priorities and deadlines in a dynamic environment.

• Attention to detail and compliance focus: High level of accuracy with a strong emphasis on GDP compliance and documentation standards.

• Operational agility: Comfortable operating in fast-paced, project-driven environments.

• Problem-solving and continuous improvement: Demonstrated capability to identify issues and drive process optimization and operational improvements.

• Adaptability and initiative: Proactive and self-directed, with the ability to anticipate challenges and drive effective solutions independently. Takes ownership of their tasks.

• Collaboration and knowledge sharing: Strong team-oriented approach. Gains consensus, leads, influences and ensures cross-discipline participation and feedback. Mentors others by sharing expertise and providing guidance.

At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support-showing up in big moments and small to help patients find comfort and confidence.

We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men’s health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.

We are Keenova-keen to solve, keen to serve. Learn more at www.keenova.com.