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Medical Device Engineer in Product Maintenance

  • manufacturing
  • Denmark - Hillerød

Would you like to have a direct impact on people’s lives by ensuring the reliability of Novo Nordisk’s insulin pens and other medical devices? If you think that navigating in a complex and controlled environment with strict regulatory requirements, whilst ensuring world-class productivity and product quality, is an interesting challenge? Then you may be our new Medical Device Engineer.

About the department
The position is located in the Design Controls team in the Product Maintenance department. Product Maintenance holds the design responsibility for Novo Nordisk’s medical devices after the device design has been transferred from R&D to production. The Design Controls team consist of 12 skilled engineers with in-depth understanding of the design control process as well as technical expertise within mechanics, electronics, software and polymers. Each team member is responsible for one or more marketed products e.g. our high quality insulin pens.

The position
In this position, you are responsible for design controls activities related to our portfolio of high volume prefilled pen-injectors for treatment of diabetes and growth disorders. On an everyday basis, you use your technical knowledge, product documentation and tools like the safety risk analysis to provide expert input and set direction during production challenges, customer complaint handling, improvement projects etc. You can for example be asked to decide on which tests to perform to verify a design change, to assess the safety risk impact of a production error, or to write a technical document for a regulatory submission. Your input has direct impact on our ability to deliver to the market, on patient safety and on compliance with the requirements of the authorities. You own much of the technical documentation related to the product’s design, and it is your responsibility to keep the documentation up-to-date e.g. during design changes.

The position provides a unique opportunity to be involved in all aspects of a medical device in an international pharmaceutical company. To succeed you collaborate with a broad range of stakeholders in the organisation as Manufacturing Development, Regulatory Affairs, Quality Assurance, Global Safety and Research & Development.

Qualifications
You have a MSc in Mechanical Engineering or similar. Your possess 3+ years of experience within the development or manufacturing of medical devices or other products where quality and regulatory compliance are vital to succeed. You have a strong technical understanding and you have experience with one or more aspects of design controls e.g. requirements engineering, design verification and safety risk management. Experience with combination products is an asset. You will work in an international environment, hence solid skills in written and spoken English is a must.

You are driven by the outlook of being the one person that our stakeholders turn to for product related decisions. You have a strong service mind-set and a willingness to understand and challenge how you create value in the organisation. You work independently both in critical situations as well as in maintenance projects with longer duration. Strong personal dedication, integrity and networking skills are needed to set direction and make decisions in a complex stakeholder environment, often with diverging interests. You are structured and have a systematic way of working, seeking simple and effective solutions within the complexity that surrounds a medical device and its documentation package.

Working at Novo Nordisk
At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development.

Contact
For further information, please contact Linda Nilsson at +45 3075 0872.

Deadline
28 February 2018.

Please note that we will invite candidates for interviews continuously throughout the posting period.


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329747881Phoenix-f8b36ce712018-01-26T03:13:32.660Medical Device Engineer in Product Maintenance
  • manufacturing
  • Denmark - Hillerød

Would you like to have a direct impact on people’s lives by ensuring the reliability of Novo Nordisk’s insulin pens and other medical devices? If you think that navigating in a complex and controlled environment with strict regulatory requirements, whilst ensuring world-class productivity and product quality, is an interesting challenge? Then you may be our new Medical Device Engineer.

About the department
The position is located in the Design Controls team in the Product Maintenance department. Product Maintenance holds the design responsibility for Novo Nordisk’s medical devices after the device design has been transferred from R&D to production. The Design Controls team consist of 12 skilled engineers with in-depth understanding of the design control process as well as technical expertise within mechanics, electronics, software and polymers. Each team member is responsible for one or more marketed products e.g. our high quality insulin pens.

The position
In this position, you are responsible for design controls activities related to our portfolio of high volume prefilled pen-injectors for treatment of diabetes and growth disorders. On an everyday basis, you use your technical knowledge, product documentation and tools like the safety risk analysis to provide expert input and set direction during production challenges, customer complaint handling, improvement projects etc. You can for example be asked to decide on which tests to perform to verify a design change, to assess the safety risk impact of a production error, or to write a technical document for a regulatory submission. Your input has direct impact on our ability to deliver to the market, on patient safety and on compliance with the requirements of the authorities. You own much of the technical documentation related to the product’s design, and it is your responsibility to keep the documentation up-to-date e.g. during design changes.

The position provides a unique opportunity to be involved in all aspects of a medical device in an international pharmaceutical company. To succeed you collaborate with a broad range of stakeholders in the organisation as Manufacturing Development, Regulatory Affairs, Quality Assurance, Global Safety and Research & Development.

Qualifications
You have a MSc in Mechanical Engineering or similar. Your possess 3+ years of experience within the development or manufacturing of medical devices or other products where quality and regulatory compliance are vital to succeed. You have a strong technical understanding and you have experience with one or more aspects of design controls e.g. requirements engineering, design verification and safety risk management. Experience with combination products is an asset. You will work in an international environment, hence solid skills in written and spoken English is a must.

You are driven by the outlook of being the one person that our stakeholders turn to for product related decisions. You have a strong service mind-set and a willingness to understand and challenge how you create value in the organisation. You work independently both in critical situations as well as in maintenance projects with longer duration. Strong personal dedication, integrity and networking skills are needed to set direction and make decisions in a complex stakeholder environment, often with diverging interests. You are structured and have a systematic way of working, seeking simple and effective solutions within the complexity that surrounds a medical device and its documentation package.

Working at Novo Nordisk
At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development.

Contact
For further information, please contact Linda Nilsson at +45 3075 0872.

Deadline
28 February 2018.

Please note that we will invite candidates for interviews continuously throughout the posting period.

2018-03-01T01:02:56.463 manufacturingDenmark - Hillerød Would you like to have a direct impact on people s lives by ensuring the reliability of Novo Nordisk s insulin pens and other medical devices? If you think that navigating in a complex and controlled environment with strict regulatory requirements, whilst ensuring world-class productivity and product quality, is an interesting challenge? Then you may be our new Medical Device Engineer. About the department The position is located in the Design Controls team in the Product Maintenance department. Product Maintenance holds the design responsibility for Novo Nordisk s medical devices after the device design has been transferred from R D to production. The Design Controls team consist of 12 skilled engineers with in-depth understanding of the design control process as well as technical expertise within mechanics, electronics, software and polymers. Each team member is responsible for one or more marketed products e.g. our high quality insulin pens. The position In this position, you are responsible for design controls activities related to our portfolio of high volume prefilled pen-injectors for treatment of diabetes and growth disorders. On an everyday basis, you use your technical knowledge, product documentation and tools like the safety risk analysis to provide expert input and set direction during production challenges, customer complaint handling, improvement projects etc. You can for example be asked to decide on which tests to perform to verify a design change, to assess the safety risk impact of a production error, or to write a technical document for a regulatory submission. Your input has direct impact on our ability to deliver to the market, on patient safety and on compliance with the requirements of the authorities. You own much of the technical documentation related to the product s design, and it is your responsibility to keep the documentation up-to-date e.g. during design changes. The position provides a unique opportunity to be involved in all aspects of a medical device in an international pharmaceutical company. To succeed you collaborate with a broad range of stakeholders in the organisation as Manufacturing Development, Regulatory Affairs, Quality Assurance, Global Safety and Research Development. Qualifications You have a MSc in Mechanical Engineering or similar. Your possess 3 years of experience within the development or manufacturing of medical devices or other products where quality and regulatory compliance are vital to succeed. You have a strong technical understanding and you have experience with one or more aspects of design controls e.g. requirements engineering, design verification and safety risk management. Experience with combination products is an asset. You will work in an international environment, hence solid skills in written and spoken English is a must. You are driven by the outlook of being the one person that our stakeholders turn to for product related decisions. You have a strong service mind-set and a willingness to understand and challenge how you create value in the organisation. You work independently both in critical situations as well as in maintenance projects with longer duration. Strong personal dedication, integrity and networking skills are needed to set direction and make decisions in a complex stakeholder environment, often with diverging interests. You are structured and have a systematic way of working, seeking simple and effective solutions within the complexity that surrounds a medical device and its documentation package. Working at Novo Nordisk At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development. Contact For further information, please contact Linda Nilsson at 45 3075 0872. Deadline 28 February 2018. Please note that we will invite candidates for interviews continuously throughout the posting period.11Jobnetf8b36ce7100000000000IDK_OFIR_02DKDanmark228DKK2018-02-28T00:00:000010https://www.novonordisk.com/careers/working-at-novo-nordisk/job-ad-display.52905BR.English.html0EuropaDanmarkEuropaDanmarkSjælland & øerStorkøbenhavnHerlevEuropaDanmarkSjælland & øerStorkøbenhavnFuresøEuropaDanmarkSjælland & øerStorkøbenhavnGladsaxe3088415NOVO NORDISK A/S11Novo Alle 12880BagsværdDKDanmark0
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