Senior Systems Engineer (all genders) (full-time, regular)

Location: Ludwigshafen, Germany; international travel may be required.

Company

hirify.global develops medicines, aesthetic products, and therapeutic solutions across areas including immunology, oncology, neuroscience, and medical devices.

What you will do

• Develop aesthetic devices and therapeutic combination products, including syringes, autoinjectors, and electromechanical pumps.
• Implement systems engineering principles across design controls, system architecture, design inputs, traceability, risk management, change management, and DHF architecture.
• Define and manage stakeholder needs, use cases, product requirements, and applicable standards throughout the product lifecycle.
• Lead system and use-related risk management, including risk assessments, reporting, and design and process FMEAs.
• Coordinate third-party development, design-control activities, testing, and deliverable acceptance.
• Own key systems-engineering deliverables and drive process improvements with cross-functional teams.

Requirements

• Bachelor’s degree in Engineering, Science, or a related discipline with 7+ years of relevant experience, or a master’s degree with 5+ years.
• Strong expertise in systems engineering, requirements definition, product architecture, configuration management, traceability, change management, and risk management.
• Experience with DHF management and design-control documentation.
• Technical leadership experience ensuring compliance with safety and regulatory requirements, including FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO 14971, ISO 13485, and EU MDR.
• Experience managing third-party vendors, deliverable acceptance testing, and cross-functional development activities.
• Excellent written and oral communication skills in English and German are required.

Nice to have

• Experience developing combination products or medical devices from concept through market release.
• Experience with aesthetic filler products.
• Scientific writing and intercultural experience in a global environment.

Culture & Benefits

• Open, diverse, and inclusive corporate culture.
• Flexible work models supporting work-life balance.
• Structured onboarding with a dedicated mentor.
• Corporate health management with health and exercise programs.
• Social benefits and career development opportunities within an international organization.