Lead Medical Device Development Engineer — Design & Risk

Cari; Hillerød; Remote; DKK 570.000 - 838.000; Vollzeit

Zusammenfassung

Novo Nordisk is seeking an Advanced Product Development Engineer to own the design, verification and robustness of medical devices from concept to life on the market. Based in Hillerød, you will translate complex requirements into documented technical choices for safe, compliant devices trusted by patients.

You will lead design-control activities, manage requirements, and collaborate across QA, Regulatory Affairs and Manufacturing. Strong English is essential; Danish not required.

Qualifikationen

• One of the following combinations of education and relevant experience in medical-device development: a PhD with 2 years, an MSc with 3 years, or a B.Sc. with 5–7 years.
• Strong working knowledge of requirements management and traceability, design-control principles, risk management, design verification and validation, technical documentation, and change control.
• Knowledge of the relevant regulations and standards, including 21 CFR 820.30, ISO 13485, ISO 14971 and EU MDR.
• Experience contributing to or leading parts of product design, system specifications and architecture, verification and validation, design transfer, formal design changes and risk‑management activities.
• The ability to handle complex technical tasks where procedures are not fully defined, evaluate known alternatives and recommend the right technical choice.
• Strong technical writing and presentation skills, and the ability to explain your recommendations and influence stakeholders when you introduce new concepts or ways of working.
• Professional-level written and spoken English. Danish is not required.
• Willingness to work on site in Hillerød.

Aufgaben

• Establish and maintain requirements, system specifications and architecture with full traceability across the device, drug, user communication and packaging interfaces.
• Lead elements of product design and drive the design‑control lifecycle, from planning, inputs and outputs to design reviews, verification, validation, design transfer and change control.
• Plan, support and lead verification and validation activities, and develop or approve technical protocols, reports and design changes within your area of expertise.
• Maintain the risk‑management file and keep it current as you learn from the product’s lifecycle.
• Lead technology assessments and selection activities, including risk‑benefit analyses of alternatives.
• Support marketed products with technical input to non‑conformities, complaints and post‑market activities, and identify improvements to processes, documentation and methodology.

Kenntnisse

Requirements management

Design-control principles

Risk management

Verification & validation

Technical documentation

Change control

Regulatory knowledge

Technical writing

English proficiency

Ausbildung

PhD with 2 years OR MSc with 3 years OR BSc with 5–7 years

Tools

CAD

PLM

CAE

Simulation

FMEA

FTA

Jobbeschreibung

Novo Nordisk is seeking an Advanced Product Development Engineer to own the design, verification and robustness of medical devices from concept to life on the market. Based in Hillerød, you will translate complex requirements into documented technical choices for safe, compliant devices trusted by patients.

You will lead design-control activities, manage requirements, and collaborate across QA, Regulatory Affairs and Manufacturing. Strong English is essential; Danish not required.