Design Control Engineer – Combination Products & Drug Delivery Systems

ALTEN; Bern; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

ALTEN is seeking a Design Control Engineer to lead design control, risk management, and technical documentation for drug-device combination products. You will collaborate across R&D, Quality, Regulatory Affairs, and Manufacturing to ensure lifecycle management and regulatory compliance.

The role focuses on respiratory, subcutaneous, and IV delivery platforms. The ideal candidate brings 5+ years in regulated environments, advanced degrees in engineering, and strong expertise in ISO 14971, MDR,

Qualifikationen

• Master’s degree or PhD in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related scientific discipline.
• Minimum 5 years in Combination Products, Drug Delivery Systems, Medical Device Development, or Pharmaceutical/Biotechnology environments.
• Strong background in Design Control, Risk Management, Product Development, Technical Documentation, and Verification & Validation.
• Experience working in regulated environments.

Aufgaben

• Develop and maintain Design Control documentation throughout the product lifecycle.
• Author and manage Risk Management documentation in ISO 14971.
• Support development, customization, qualification, and optimization of drug delivery systems.
• Contribute to Design Verification and Validation activities.
• Assist in technology transfer and industrialization.
• Prepare technical documentation for quality and regulatory submissions.
• Collaborate with R&D, Quality, Regulatory Affairs, Technical Operations, and external partners.
• Ensure compliance with regulatory requirements and industry standards.
• Stay updated on industry trends, regulations, and best practices in Combination Products and Drug Delivery.

Kenntnisse

Design Control

Risk Management

Technical Documentation

Verification & Validation

Drug Delivery

Regulated Environments

Ausbildung

Masters/PhD in relevant field

Jobbeschreibung

Join a global leader in the pharmaceutical industry as a Design Control Engineer within the Combination Products Development team, and play a pivotal role in design control, risk management, technical documentation, and cross-functional collaboration with R&D, Quality, Technical Operations, and Manufacturing teams. This role focuses on the development, optimization, and lifecycle management of cutting-edge drug-device combination products for respiratory, subcutaneous, and intravenous drug delivery.

Key Responsibilities

• Develop and maintain Design Control documentation throughout the product lifecycle.
• Author and manage Risk Management documentation in compliance with ISO 14971.
• Support the development, customization, qualification, and optimization of drug delivery systems and combination products.
• Contribute to Design Verification and Validation activities.
• Participate in Design Reviews and technical assessments.
• Assist in technology transfer and industrialization activities.
• Prepare technical documentation for quality and regulatory submissions.
• Collaborate with R&D, Quality, Regulatory Affairs, Technical Operations, and external partners.
• Ensure compliance with regulatory requirements and industry standards.
• Stay updated on industry trends, regulations, and best practices in Combination Products and Drug Delivery Systems.

Required Qualifications

• Master’s degree or PhD in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related scientific discipline.
• Minimum 5 years in Combination Products, Drug Delivery Systems, Medical Device Development, or Pharmaceutical/Biotechnology environments.
• Strong background in Design Control, Risk Management, Product Development, Technical Documentation, and Verification & Validation.
• Experience working in regulated environments.

Hands-on experience with the following are highly appreciated:

• Autoinjectors, Pen Injectors, Prefilled Syringes, Safety Syringes, Inhalation Devices, or Drug Delivery Platforms.
• Human Factors Engineering or Usability Engineering.
• ISO 14971, ISO 13485, FDA Design Controls, MDR, or Combination Product regulations.