Ingénieur Système / Systems Engineer

Stryker; Brest; On-site; EUR 38,000 - 62,000; Full time

Job summary

Stryker in Brest, France, is seeking a biomedical/engineering-focused engineer to design, develop and verify medical device systems under supervision. You translate user needs into system requirements and contribute to architecture, verification and risk management activities.

You will work with cross-functional teams to ensure design controls, document Design History File content, and support system integration testing in a regulated environment aligned with ISO 13485 and ISO 14971.

Qualifications

• Bachelor degree in engineering required.
• 0+ years of work experience preferred.
• Basic knowledge of requirements management tools and system architectures.

Responsibilities

• Design, develop, modify, and verify medical device systems under supervision.
• Translate user needs to system requirements.
• Modify existing system architecture or test designs.
• Assist with Concept Phase activities.
• Support problem solving and root-cause analysis.
• Learn R&D procedures like design controls and risk management per QMS.
• Work with stakeholders to ensure project success.
• Contribute to engineering documentation per design control procedures.

Skills

Requirements management

SysML

MBSE

ISO 13485

ISO 14971

Education

Bachelor of Science in Software, Electrical, Mechanical, Systems, or Biomedical Engineering

Tools

Jama

SysML MBSE software tools

Job description

Who we want:

Describe the open role, highlighting key responsibilities and tasks. This verbiage will be used in job postings to draw in potential candidates.

What you will do:

Technical Responsibilities: Under supervision:

• Design, develop, modify, and verify medical device systems
• Translate user needs to system requirements
• Modify existing system architecture or test designs
• Assist with Concept Phase activities
• Support problem solving, root cause analysis, identify potential solutions, and evaluate them against requirements
• Under supervision, execute analytical study protocols, including trade studies, sensitivity studies, optimization studies, performance assessments, and design assessments
• Participate in system integration testing
• Execute verification tests according to an established protocolBusiness Responsibilities:
• Interpret customer needs and understands design inputs
• Understand the product’s intended use and clinical proceduresMed Device Compliance:
• Understand fundamental industry standards, design requirements and test strategies which align with regulatory requirements
• With supervision, create or refine engineering documentation, such as the Design History file per company design control procedures
• Learn R&D procedures like design controls and risk management, per the Quality Management SystemGeneral Responsibilities:
• With supervision, work with a variety of stakeholders to ensure project success
• Learn procedures, policies, processes, systems, and technology required
• Work on problems in limited scope; purposefully learn while gaining experience
• Demonstrate ownership and integrity of work
• Build stable relationships
• Contribute to the project as a team memberMinimum Qualifications (Required):
• Bachelor of Science in Software, Electrical, Mechanical, Systems, or Biomedical Engineering & 0+ years of work experiencePreferred Qualifications (Strongly desired):Technical Skills:
• Fundamental knowledge and understanding of requirement and verification practices
• Basic knowledge of Requirements Management Tools
• Ability to read and Interpret system architecturesPreferred Skills / Engineering tools:
• Requirements Management Software, especially Jama
• Experience with SysML and Model-based Systems Engineering
• Experience with SysML / MBSE software tools
• Knowledge of ISO 13485 and ISO 14971

France Pay Ranges:

• France: €37.500 - €62.400 EUR Annual

At Stryker, we believe transparency helps candidates make confident decisions about their next career step. Compensation is an important part of that process and we want to be clear about how pay is determined. The compensation information posted for this role may be presented as a salary range or a fixed amount depending on the role. In addition to base salary, this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable), along with Stryker’s comprehensive benefits package.

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.