Advanced Product Development Engineer

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

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As a Advanced Product Development Engineer, you will take technical ownership of how medical devices are designed, verified and kept robust, from concept through life on the market. You will make the design-control and risk decisions that keep each device safe, compliant and ready for the people who rely on it. Based in Hillerød, you will turn complex requirements into well-documented technical choices, helping people living with serious chronic diseases trust the devices they use every day.

What you’ll bring

You have hands-on experience in medical-device development and design control. You can operate independently once you have learned the specific products and context, and documentation is something you care about getting right.

• One of the following combinations of education and relevant experience in medical-device development: a PhD with 2 years, an M.Sc. with 3 years, or a B.Sc. with 5–7 years.
• Strong working knowledge of requirements management and traceability, design-control principles, risk management, design verification and validation, technical documentation, and change control.
• Knowledge of the relevant regulations and standards, including 21 CFR 820.30, ISO 13485, ISO 14971 and EU MDR.
• Experience contributing to or leading parts of product design, system specifications and architecture, verification and validation, design transfer, formal design changes and risk-management activities.
• The ability to handle complex technical tasks where procedures are not fully defined, evaluate known alternatives and recommend the right technical choice.
• Strong technical writing and presentation skills, and the ability to explain your recommendations and influence stakeholders when you introduce new concepts or ways of working.
• Professional-level written and spoken English. Danish is not required.
• Willingness to work on site in Hillerød.

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

Salary: The annual base salary for this role ranges from DKK 570,200 to DKK 838,100 , 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

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 .

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