Senior Medical Device Development Engineer

Novo Nordisk; Hillerød; On-site; DKK 570,000 - 838,000; Full time

Benefits offered by this job

Continuous learning

Career development

Competitive benefits

Job summary

Novo Nordisk seeks an Advanced Product Development Engineer to own device design, verification and robustness from concept to market. Based in Hillerød, you will translate complex requirements into documented technical choices, ensuring device safety, compliance and patient trust.

You will contribute to regulatory submissions, risk management and lifecycle improvements while collaborating with cross-functional teams across Global Manufacturing & Supply. English is required; Danish is not.

Qualifications

• PhD with 2 years, M.Sc. with 3 years or B.Sc. with 5–7 years in medical-device development.
• Strong knowledge of requirements management and traceability, design-control, risk management, V&V, documentation, and change control.
• Familiarity with 21 CFR 820.30, ISO 13485, ISO 14971 and EU MDR.
• Experience leading design activities and risk-management tasks.
• Ability to tackle complex tasks with limited procedures and to justify technical choices.
• Excellent technical writing and presentation skills with stakeholder influence.
• Proficient English; Danish not required.
• Willingness to work on site in Hillerød.

Responsibilities

• Establish and maintain requirements, system specs and architecture with full traceability across interfaces.
• Lead elements of product design and drive the design-control lifecycle from planning to change control.
• Plan, support and lead verification and validation activities with protocols and reports.
• Maintain and update the risk-management file throughout the product lifecycle.
• Lead technology assessments and risk-benefit analyses of alternatives.
• Provide technical input to non-conformities and post-market activities, and drive process improvements.

Skills

Medical-device development

Design control

Requirements management

Risk management

Documentation

Technical writing

English proficiency

Education

PhD + 2 years

M.Sc. + 3 years

B.Sc. + 5-7 years

Tools

CAD

PLM

CAE

Simulation

FMEA

FTA

Requirements management platform

Job description

Novo Nordisk seeks an Advanced Product Development Engineer to own device design, verification and robustness from concept to market. Based in Hillerød, you will translate complex requirements into documented technical choices, ensuring device safety, compliance and patient trust.

You will contribute to regulatory submissions, risk management and lifecycle improvements while collaborating with cross-functional teams across Global Manufacturing & Supply. English is required; Danish is not.