Product Development Engineer

Cari; Hillerød; Remote; DKK 500,000 - 734,000; Full time

Job summary

Novo Nordisk in Denmark is seeking a Product Development Engineer to turn user needs into well-designed, well-documented devices for people with serious chronic diseases. You will support design controls, risk management and verification, ensuring traceability of technical decisions.

This is a regulated environment where you contribute from day one. You will own technical integrity across the development lifecycle, establish requirements and architecture with full traceability, lead

Qualifications

• Bachelor or Master in engineering or related field and strong analytical mindset.
• Experience in product development, design controls, risk management and documentation.
• Ability to follow established design-control processes and ensure traceability.

Responsibilities

• Establish and maintain requirements, system specifications and architecture with full traceability.
• Lead design-control lifecycle activities from planning to change control.
• Plan and lead verification and validation activities and develop technical protocols and reports.
• Maintain and update the risk-management file across the product lifecycle.
• Support non-conformities, complaints and post-market activities with technical input.

Skills

Analytical thinking

Attention to detail

Documentation

Communication

Independence

Education

B.Sc. in Engineering

M.Sc. in Engineering or related field

Tools

CAD

PLM

CAE

FMEA

FTA

Requirements mgmt

Job description

Product Development Engineer

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

• 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-cause 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

Learn more about our Reward Philosophy.

For further information

Sr Manager Bjarke Jørgensen at BJDJnovonordisk.

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