Systems Engineer Hardware

Essential Responsibility (Description of responsibility area, eg –Personnel,  -Acceptance, -Budget, -Instrument, -Systemowner IT. )

Develop hardware solutions and refine the design for legacy products, by coordinating and implementing improvements.

Authority (Description of official authority connected to the employment after completed education or training. E.g. this employment has the authority to add new methods to the system.)

• Decision-maker and approver of documentation within the defined area of responsibility.
• Issuer of design change activities (internal and external change requests).
• Issuer of drawings and technical specifications.
• Reviewer and, where applicable, approver of drawings and specifications.

MAIN TASKS

(Short task description)

• Coordinate and execute activities within the change control process.
• Develop, validate, and maintain instructions and test methods supporting the production of hardware (HW) products.
• Ensure cross-functional collaboration to verify that design and performance requirements are fulfilled.
• Transfer and maintain product specifications to manufacturing.
• Coordinate troubleshooting, root cause analysis, and continuous improvement for HW products.
• Develop and maintain design-related activities for product lifecycle management and product care.
• Ensure compliance with international regulatory standards and quality system requirements applicable to product development and design activities, including support for audits and inspections.

Qualifications/Requirements FOR POSITION

Level of formal education

Preferred qualifications:

• Bachelor of Science or equivalent in Electrical Engineering, Mechanical Engineering, or other relevant technical discipline.
• Proficiency in E-CAD software required; OrCAD experience preferred.
• Experience with Product Data Management (PDM) systems required; Windchill preferred.
• Familiarity with CAD software desirable; PTC Creo preferred.
• Minimum of three years’ experience in a regulated industry (pharmaceutical, life science or medical device or similar).

Miscellaneous Qualifications/Requirements

• Professional-level proficiency in written and spoken English.
• Ability to work independently, manage priorities, and take ownership of tasks, processes, and timelines.
• Demonstrated capability to work effectively across departments in a matrix organization.
• Strong self-leadership, communication, and presentation skills.
• Result-oriented mindset with the ability to influence and drive outcomes in cross-functional contexts.
• Excellent organizational and time management skills to handle multiple concurrent activities.