Job Title: Medical Device Engineer – Combination Products
Employment Type: Full-Time/ Contract
Overview
Position Summary: We are looking for an experienced and hands-on Device Engineer to support the full lifecycle of combination product development and manufacturing. This role is based primarily on-site with the client, with occasional flexibility for home office work.
The successful candidate will play a key role in the design transfer, automation support, and production readiness of drug-device combination products, with a focus on robotized assembly lines and cross-functional collaboration from development through to commercial manufacturing.
Responsibilities
* Support device-related activities across development, execution, qualification, and production phases (F2P2) for combination products.
* Collaborate with cross-functional teams to implement and optimize automated assembly solutions for medical devices.
* Participate in the commissioning, qualification, and validation of production equipment and processes.
* Act as a technical point of contact for equipment and device component interfaces, ensuring seamless integration.
* Troubleshoot technical issues and support root cause investigations related to assembly processes and equipment.
* Ensure compliance with regulatory and quality standards throughout all phases of the product lifecycle.
* Support continuous improvement initiatives in device assembly and production systems.
* Provide technical input and documentation to support audits, design history files, and technical files.
Qualifications
* Degree in Mechanical Engineering, Biomedical Engineering, or a related technical field.
* 3+ years of experience in medical devices, combination products, or a similarly regulated industry.
* Solid understanding of automated assembly systems, preferably with experience in high-precision or robotized lines.
* Knowledge of design control, validation, and manufacturing processes for regulated medical products.
* Familiarity with quality and regulatory standards such as ISO 13485, EU MDR, or 21 CFR Part 820.
* Strong communication, analytical, and organizational skills.
* Fluent in English; German language skills are a plus.
Note: The original document contained additional job links and references to other roles. Those items have been omitted to maintain a focused, production-ready posting.
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