Senior Systems Engineer (Aesthetic Filler & Combination Products)

Quick Facts

• Role: Senior Systems Engineer for Aesthetic Filler & Combination Products

• Team/Focus: Device and Combination Product Development (R&D)

• Location: Wiesbaden, Germany

• Travel: 10–20%

Description

You will lead Systems Engineering activities within the Design Controls process for aesthetic devices and therapeutic combination products. You will define stakeholder needs and product requirements, drive risk management and DHF documentation, and coordinate third-party development and testing planning with cross-functional teams. You will serve as the dedicated systems engineer owning key deliverables and ensuring successful project execution.

Responsibilities

• Implement holistic Systems Engineering principles within Design Controls, covering system architecture and integration, Design Inputs, traceability, risk management, change management, and DHF architecture.

• Define and manage user and stakeholder needs, use cases, product requirements, and applicable standards across the product development lifecycle.

• Lead system and use-related risk management activities, including risk planning and reporting, system risk assessments, and design and process FMEAs.

• Oversee and integrate third-party development activities and ensure alignment with Design Control and Quality by Design activities.

• Collaborate across functions to identify process gaps, recommend and implement improvements, and standardize methods to improve consistency and efficiency.

• Plan and coordinate testing activities, including sample and laboratory resource planning, and improve processes and ways of working.

• Act as the dedicated systems engineer, independently owning key deliverables and coordinating stakeholder input.

Requirements

• Bachelor’s degree in Engineering, Science, or a closely related discipline with 7+ years relevant experience, or Master’s degree with 5+ years relevant experience.

• Proven technical leadership to ensure system design and documentation comply with applicable safety and regulatory requirements.

• Product development experience from initial concept to market release; direct experience with combination product or medical device development is desired.

• Familiarity with FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO 14971, ISO 13485, and EU MDR (preferred).

• Strong Systems Engineering expertise: stakeholder/user needs definition, requirements definition, risk management, product architecture, configuration management, traceability, and change management.

• Expertise in DHF management and creation of Design Control documents compliant with regulations.

• Strong analytical and problem-solving skills for decision-making, risk identification, and mitigation plans.

• Experience working with third-party vendors, including vendor communication, management, and deliverable acceptance testing.

• Experience in intercultural global environments.

• Aesthetic Filler product experience preferred.

• Strong written and verbal communication skills (scientific writing), structured self-driven priority and timeline management.

• Fluent English and German; willingness to travel internationally (10–20%).

Benefits

• Diverse work environment and open corporate culture

• Attractive salary

• Intensive onboarding with a mentor

• Flexible work models

• Health and exercise programs and social benefits

• Career and development opportunities in an international organization

• Commitment to equality, equity, diversity, and inclusion, with support for employee well-being and work-life balance