Principal Device Engineer

Roche; Basel; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Roche is seeking a senior mechanical engineer to lead the development of medical device and drug-delivery systems. You will drive robust engineering practices, collaborate with QA, Regulatory, and Clinical teams, and ensure products meet stringent quality and regulatory standards across the lifecycle.

The role requires a strong background in parenteral delivery systems, materials science, and hands-on experience with device design controls. Fluency in English is required; German is a plus.

Qualifikationen

• Bachelor's or Master's degree in engineering from an accredited institution.
• 10+ years in mechanical engineering and drug delivery device development in regulated environments.
• Hands-on expertise with pen injector and autoinjector development across product lifecycle.

Aufgaben

• Drive robust development of drug-delivery devices and combination products across lifecycle.
• Provide technical leadership and problem-solving to ensure design robustness and compliance.
• Lead investigations and document design controls, URS, design inputs/outputs, verification/validation plans.
• Collaborate with QA, Regulatory, Clinical, and Commercial teams to meet regulatory expectations.

Kenntnisse

Mechanical engineering

Drug delivery

Regulatory compliance

Cross-functional leadership

Design controls

Materials science

Parenteral delivery

QA/QC awareness

Ausbildung

BSc or MSc in engineering

Jobbeschreibung

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Global Technical Development (PTD) is an organization of over two thousand people globally that are integral for the mission of Roche to develop meaningful medicines for patients. Therefore, we actively collaborate and develop creative technical solutions to bridge early-stage, late-stage and commercial product needs. The mandate is to expertly deliver the pipeline and supply quality products to patients.

The Device Development department within Roche Technical Development is responsible for the development and support of drug delivery devices for the product portfolio. Our activities span a range of engineering disciplines from the requirements definition phase through to commercialization and marketed product support.

Device Engineering combines design, engineering, testing, and manufacturing to develop reliable and safe drug delivery devices that meet the needs of patients, healthcare providers and Health Authorities.

The opportunity

This hands‑on role drives engineering excellence by applying design controls, solving complex device engineering challenges, and providing strategic technical guidance to ensure robust product development and compliance.

In this role, you will engage in cross‑functional collaboration, particularly with Quality Assurance, Device MSAT, Regulatory Affairs, Pharmaceutical Development, Clinical, and Commercial teams.

• Serve as the Technical Project Lead or Subject Matter Expert to drive the robust development of combination products and medical devices, ensuring a seamless advancement into clinical phases and commercial market applications.
• Apply deep engineering expertise and strategic insights, establish robust technical product requirements and develop drug‑device combination product design solutions to assure devices maintain the required level of performance throughout the entire product lifecycle.
• Collaborate with external partners providing technical oversight on mechanical designs for combination products while ensuring high performance, design robustness and fostering innovation.
• Lead internal and external technical investigations to swiftly resolve complex, design‑related issues using structured problem‑solving methodologies.
• Author and manage comprehensive design control documentation – including Design Development Plans, User Requirements Specifications (URS), Design Inputs/Outputs, Verification/Validation Plans, conformity assessments, and risk management files.
• Navigate the global regulatory landscape to ensure all product designs and processes comply with industry standards, specifically ISO 13485, ISO 14971, and 21 CFR Part 820 (with an emphasis on 820.30 Design Controls).

Who you are

• University degree (BSc or MSc) in engineering or a related technical discipline from an accredited institution.
• 10+ years of experience in mechanical engineering and drug delivery device development within pharma or highly regulated environments (cGxP, QSR).
• Hands‑on expertise in pen injector and autoinjector development throughout the entire product lifecycle.
• Strong background in container closure systems, specifically prefilled syringes and cartridges for parenteral drug delivery.
• Proven technical leadership and advanced problem‑solving capabilities in cross‑functional team environments.
• Solid understanding of materials science applied to drug delivery systems, with expertise in damage mechanisms, defect identification, and performance testing.
• Deep knowledge of regulations, industry standards, and guidance for combination products and medical devices on a global scale.
• Direct experience navigating Health Authority interactions and managing regulatory submissions.
• Technical proficiency in parenteral drug delivery, risk assessment, tolerance analysis, statistical techniques, process capability, and reliability engineering to resolve complex issues.
• Excellent communication skills, strategic thinking, and strong documentation/presentation capabilities to effectively influence stakeholders.
• Fluency in English is required for this global role; German proficiency is a plus.

Roche is an Equal Opportunity Employer.