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

Your impact begins here

As a Product Development Engineer, you will help turn user needs into well-designed, well-documented devices that people living with serious chronic diseases can rely on. You will support design controls, risk management and verification work, making sure each technical decision is traceable and backed by evidence. This is a place to build your craft in a regulated environment and contribute from day one.

What You’ll Bring

You bring a solid engineering foundation, a careful eye for detail and the curiosity to learn how a regulated product comes together.

• A B.Sc. or M.Sc. in Engineering, Biomedical Engineering or a related field.
• 3 years of relevant professional experience.
• A foundational understanding of product development principles and the ability to follow established design-control processes and procedures.
• Foundational knowledge of requirements management and traceability, risk management, design verification and validation, technical documentation and change control.
• An analytical, systematic approach to solving problems of limited scope, and a quality-focused, risk-based way of working.
• Strong attention to detail, particularly in documentation, traceability and compliance.
• Clear written and verbal communication, and the ability to contribute to design reviews and document technical decisions.
• The ability to work independently on routine assignments, while asking for guidance on new or more complex tasks.

Useful, But Not Essential

• Experience with system architecture and interface definition across medical devices, drug-device interfaces, user communication and primary or secondary packaging.
• Practical experience with CAD, PLM, CAE, simulation, statistical methods or requirements-management platforms, and with FMEA and FTA.
• Experience with material science, component selection or supplier quality management.
• Experience preparing technical content for regulatory submissions, or exposure to audits, inspections and notified bodies.
• Experience supporting marketed products, for example root-ca analysis, complaint investigations, deviations, post-market surveillance and lifecycle risk assessment.

What You’ll Do

You will own technical integrity, compliance and risk for your devices across the development lifecycle and decide how to get there within the scope of your role.

• 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.

Who You’ll Work With

You will join Global Manufacturing & Supply, where colleagues work across the value chain, from drug and device development to marketed Novo products. You will work independently, with occasional guidance from your manager and senior colleagues. Single Dose Device Team headed up by Sr Manager Bjarke Jørgensen.

Day to day, you will coordinate with cross-functional product development teams and with colleagues in Quality Assurance, Regulatory Affairs, Medical & Science, Product Supply, Global Safety and post-market surveillance. Externally, you will work with suppliers, contract manufacturers, test laboratories and technology partners, and where the work requires it, with regulatory authorities and notified bodies.

The role is based in Hillerød and primarily performed in Denmark. Travel is part of the role to support verification and validation, audits and inspections, design transfer to manufacturing sites and supplier assessments (expected travel frequency 10 days). You will often need to bring colleagues with different priorities along with new concepts, so clarity and a sense of urgency matter.

What You Can Expect Here

You will be trusted to make daily technical decisions and approve documentation within your scope, with clear performance expectations. You will build new skills through the work itself, relevant learning offerings, and experience across the development lifecycle, from innovation to post-launch, including training, conferences and technical publications.

You will be encouraged to give and receive honest feedback, speak up when things stall and share what you learn across the department.

What We Offer

At Novo, you will join a global healthcare company with a distinctive culture and a strong track record. We offer continuous learning, career development and benefits tailored to your life and career stage.

Salary

The annual base salary for this role ranges from DKK 499,600 to DKK 734,400, depending on the level of the position. Placement within the range will be assessed during the recruitment process based on the candidate’s skills, competencies, knowledge and relevant experience.

Incentives and benefits

The compensation package may include short-term and/or long-term incentives, together with other employee benefits based on position level, location, functional area and relevant market benchmarks. Learn more about our Reward Philosophy here.

For further information, please contact Sr Manager Bjarke Jørgensen at [e-mail].

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.