Engineering Manager – Support across Manufacturing, Design and Continuous Improvements
Do you want to manage a global team of engineers and technical support staff? Can you cover complex processes across manufacturing, design transfer, product design support for released products, continuous improvement projects and manage iterations of released products? Can you, in a global matrix set-up, manage multiple stakeholders across R&D and the business? Then, we urge you to continue reading.
The role as Engineering Manager is situated close to Copenhagen, and your 10 very skilled direct reports will be situated in different time zones, and you will report to a manager situated in the US.
Your responsibilities will include leading and developing your team of approx. 10 skilled engineers, who, in the product development process, are responsible for developing manufacturing, assembly and test plans, and assuring design for manufacturability. Also, you are expected to take lead in prioritizing the projects, developing project plans, and communicating these to the right stakeholders, and to ensure that your team delivers according to compliance and governance. In your work, you will get the opportunity to interact with co-workers, suppliers and customers. Your tasks, among others, include:
- Lead projects for released products to reduce cost and improve performance, quality and reliability.
- Communicate priorities, project updates and projects risk at a high level to senior leaders within the organization.
- Interface cross-functionally to identify opportunities and solve product related problems.
- Ensure that your team is proficient with all Quality System procedures, and assure that process and product changes are reviewed, approved and validated prior to implementation.
- Ensure proper development of medical device design documentation that is compliant with FDA design controls and good documentation practices.
- Oversee performance and safety testing and maintain product compliance with applicable FDA, CMDCAS, CE, IEC 60601 and UL standards as well as other regulatory requirements.
- Monitor design changes to assure effective design practices and proper verification and validation. Provide guidance and input on project work estimates.
We expect you to be a technically proficient leader with a deep insight within development of medical devices, combined with a strong track record of leading and motivating engineers. As a person, you are curious about developing yourself, both technically and as a leader, and you get a positive motivation out of engaging and developing others. You may be at a point in your career, where you want to be part of an organization that works truly globally. You supplement your personal skills with professional qualifications such as:
- Bachelor of Science in applicable Engineering or Manufacturing Management field.
- 7-10 years of experience from a manufacturing environment and experience from medical devices and mixed technologies (electronics, electro-mechanical, mechanical, software-based products).
- Minimum 5 years of experience as people manager for a team of engineers.
- Proficient with test strategies and test platforms for electronic based products.
- Competency in FDA Quality Systems Regulations, Current Good Manufacturing Practices, ISO 13485 Quality Management Systems, and medical device risk management (ISO 14971)
- Competency in human factors engineering and usability engineering for medical devices (IEC 60606-1, IEC 62366, ANSI/AAMI HE75).
- Competency in medical device safety standards (IEC 60601).
Hudson Nordic collaborates with our client about this role, and at this stage, our client wishes to be anonymous. When you apply for this, you accept that Hudson Nordic keeps your papers, and you also accept that we can forward your application and resume to our client.
To apply, please click “ansøg” in the top left of this page.
Our client will treat your information confidentially and delete all information if you do not proceed in the process. You will be informed and receive further information if our client wishes to engage in a dialogue with you.