Regulated Medical Device Product Development Engineer

Novo Nordisk; Hillerød; On-site; DKK 500,000 - 734,000; Full time

Benefits offered by this job

Health insurance

Continuous learning

Job summary

Novo Nordisk is seeking a Product Development Engineer based in Denmark to turn user needs into well-documented, regulated devices. You will support design controls, risk management and verification across the development lifecycle, contributing from day one in a regulated environment.

You will own technical integrity and documentation, with opportunities to lead verification activities and collaborate across cross-functional teams. Travel within Denmark may be required.

Qualifications

• Bachelor's or Master’s degree in Engineering or related field.
• 3 years of relevant professional experience.
• Follows design-control processes and documentation.
• Knowledge of requirements management and traceability, risk management, verification and validation, technical documentation, and change control.
• Analytical, risk-based problem solving with attention to details.

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.
• Plan, support and lead verification and validation activities with technical protocols and reports.
• Maintain the risk-management file and update as the product lifecycle evolves.
• Lead technology assessments and risk-benefit analyses of alternatives.
• Support marketed products with technical input to non-conformities and post-market activities.

Skills

Engineering basics

Attention to detail

Documentation

Traceability

Regulated environment

Education

B.Sc./M.Sc. in Engineering or related

Tools

CAD

PLM

CAE

FMEA

FTA

Job description

Novo Nordisk is seeking a Product Development Engineer based in Denmark to turn user needs into well-documented, regulated devices. You will support design controls, risk management and verification across the development lifecycle, contributing from day one in a regulated environment.

You will own technical integrity and documentation, with opportunities to lead verification activities and collaborate across cross-functional teams. Travel within Denmark may be required.