Senior Medical Device Development Engineer (On Site)

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

Job summary

Novo Nordisk A/S in Denmark seeks an Advanced Product Development Engineer to own technical integrity, compliance and risk for devices across the development lifecycle. You will decide how to meet regulatory and product goals within your scope.

You will collaborate with Global Manufacturing & Supply teams, drive design-control activities, and ensure full traceability from concept to market. On-site in Hillerød with travel for audits and validation.

Qualifications

• Medical-device development experience with design control.
• Education/experience combinations: PhD + 2 yrs, MSc + 3 yrs, or BSc + 5–7 yrs.
• Knowledge of requirements management, traceability, design-control, risk management, V&V, tech docs, change control.
• Familiarity with 21 CFR 820.30, ISO 13485, ISO 14971, EU MDR.
• Strong technical writing, presentation skills, and stakeholder influence; English required; Danish not required.

Responsibilities

• Establish and maintain requirements, system specs and architecture with full traceability across interfaces.
• Lead design elements and drive the design-control lifecycle: planning, inputs/outputs, reviews, V&V, transfer, changes.
• Plan, support and lead verification and validation activities with protocols and reports.
• Maintain the risk-management file and keep it current through lifecycle learning.
• Lead technology assessments and selection, including risk-benefit analyses.
• Support marketed products with technical input to non-conformities, post-market activities, and process improvements.

Skills

Requirements management

Traceability

Risk management

Technical writing

Stakeholder influence

Education

PhD + 2 years

MSc + 3 years

BSc + 5–7 years

Tools

CAD

PLM

CAE

Simulation

FMEA

FTA

Job description

Novo Nordisk A/S in Denmark seeks an Advanced Product Development Engineer to own technical integrity, compliance and risk for devices across the development lifecycle. You will decide how to meet regulatory and product goals within your scope.

You will collaborate with Global Manufacturing & Supply teams, drive design-control activities, and ensure full traceability from concept to market. On-site in Hillerød with travel for audits and validation.