Senior Design Assurance Engineer for medical device development
Phillips Medisize is looking for an experienced Senior Design Assurance Engineer for Global Innovation Development EU in Struer, Denmark. If you have a passionate interest in creating unique products for people who need medical treatment and want to be part of a rapidly expanding project organization, you might be the one we are looking for.
About the position:
As Design Assurance Engineer you will be part of the project from start of development until product launch. You will typically be allocated to one or two of these projects depending on phase, size and complexity. Your main role is to be responsible for the design assurance activities in the development projects. You, the project manager and the rest of the core group will pro-actively set the quality expectations for the project. You will be key to assure that our Quality Management System (QMS) is followed and we fulfil both customer and regulatory requirements. Further you will support our effort to continuously improve our QMS.
The position requires both internal and external cross functional cooperation and communication.
What we are looking for in you:
Master or Bachelor degree in Mechatronics / Mechanical / Electronic Engineering or similar qualifications. More than 10 years experience as a Design Assurance engineer – preferably in the medical device industry.
You also have proven experience with:
- life science quality management systems and standards (eg. ISO 13485:2016)
- risk based quality activity planning
- product transfer from development to production
- authority inspections/audits
- preparing material for regulatory approval
You are analytical and theoretical well-grounded. You have a systematic approach to your work and you deliver well-structured results. You have a holistic can-do attitude, a pro-active approach and deliver on time. You thrive in a changing environment and by working across many disciplines – some of these are probably new to you. You have excellent written and verbal communication skills in English.
We offer you
- A challenging position in an international innovative and successful company in growth
- An opportunity to become part of a team of dedicated and highly qualified design assurance colleagues based in Struer, Denmark
- Cooperation in cross-functional project teams with great opportunities to influence the daily work
- Participation in developing the quality (and regularory) area ensuring that we are up-to-date on relevant standards, best practices and tools
- Well-structured training and continuous development of your competencies.
- Flexible working hours
- Salary on a competitive level
Are you curious to get more information?
For more information and details on the position please contact Director, Quality and Regulatory Jess Pihl on phone +45 26 75 32 00.
We look forward to hearing from you.
We processes applications continuously. Please submit your application and CV soonest possible to by presseing the “apply” button.
The Company – in short
Phillips-Medisize A/S is an excellent expert in the design, development and delivery of advanced drug delivery devices and connected health solutions. Our customers are leading pharmaceutical companies worldwide.
Phillips-Medisize A/S is a part of Molex. We offer innovative and integrated solutions supported by an end-to-end service offering from Strategy to Launch.
Read more about Phillips-Medisize A/S at www.phillipsmedisize.com or follow us at LinkedIn.