Hybrid Systems Engineer

at Stryker

• Job title: Systems Engineer
• Job type: Full Time
• Experience level: Junior, Mid level
• Salary: Not specified
• Degree requirement: Professional Certificate
• Location requirements: Hybrid, Brest, France

About the role

• System Engineer responsible for medical software design and lifecycle management in surgical products. Collaborating with international teams to ensure high-quality regulatory compliance.

Responsibilities

• Prepare and lead product design phases with the Product Owner, development team and Quality department.
• Participate in the creation and maintenance of design documentation throughout the medical device lifecycle.
• Contribute to risk management, product safety and device usability together with the project team and the Quality department.
• Take part in design reviews as well as verification and validation phases, ensuring performance, quality and regulatory compliance objectives are met.
• Establish working relationships with stakeholders to successfully meet software delivery deadlines that align with customer expectations and to support regulatory submissions.
• Collaborate with Clinical, Legal, Commercial and Post-market Surveillance teams.
• Contribute to quality activities (non-conformities (NC), CAPA and complaints) and lead corrective action plans when required.
• Participate in audits and inspections to respond to questions regarding design and product development.

Requirements

• Engineering degree or Master’s in biomedical engineering, computer science or a related discipline.
• Minimum 2 years of professional experience in a systems integration and/or V&V engineer role.
• Strong English language skills required.
• Knowledge of agile software principles and the software development lifecycle, ideally within a regulated environment.
• Knowledge of medical device regulations: ISO 13485, ISO 14971, EN 62304, 21 CFR 820 (FDA).
• Experience formalizing customer specifications to define a validation strategy.
• Experience contributing to a design dossier for software or a medical instrument is a plus.
• Experience in medical software validation is a plus.
• Attention to detail, strong writing skills, rigor and effective time management.

Benefits

• Career development: Opportunities for vertical and horizontal progression supported by ongoing training programs to develop your skills and expertise.
• Great Place to Work: Work for the 8th best company in the "Great Place to Work" ranking.
• Work environment: A collaborative R&D environment that promotes the use of agile methodologies, ensuring efficiency and innovation throughout the development cycle.
• Global impact: Join a team whose solutions are transforming surgical procedures and improving patient outcomes worldwide.
• Competitive compensation: An attractive salary and benefits package, including health insurance, a retirement plan and performance-based bonuses.
• Innovation culture: Be part of a company where creativity and new ideas are encouraged to meet clinical needs and shape the future of healthcare.