Project Manager, Medical Devices
Location: Copenhagen, Denmark
LiNA Medical Denmark is looking for a Project Manager within the medical device field.
Your main responsibility is to secure progress and quality in bringing our devices to market. You will be working from our facility in Denmark, but also closely with colleagues internationally.
Ideally, you have practical experience with Project Management in product development of medical devices – and you are able to supplement this with a solid understanding of the process steps required to meet the requirements of the MDD/MDR.
Experience in the medical device business is a requirement while experience within product development is preferred.
Status: Out of date
Area of responsibility
You will be given the responsibility for driving the projects forward. This is done together with a both local and international based project team, and you are, therefore, able to act internationally and comfortable in this role. It is a priority that you understand the design control procedures and thus able to engage with the RA department and the R&D Design Control Specialists.
Your primary area of responsibility is bringing new products to market, but you will also be participating in, and from time to time be driving, activities of cross-departmental character; audits, CAPA’s and change requests when necessary.
Other relevant competencies you bring into the job are very welcome. In this job you will have the opportunity to utilize all your skills – to the benefit of your professional ambitions, the projects, and the department as a whole.
Key tasks/success criteria
- Plan and execute product development projects accordingly.
- Establish a strong project team – where the potential of the team is realized.
- Make decisions for the team on a day-to-day basis to simultaneously secure progress and the correct level of quality.
- Engage in Design Control activities – you will be the primary sparring partner for the Design Control team.
- Deliver results and documentation to support these.
- Engage with colleagues and stakeholders internationally.
- Be hands-on, this is key in creating progress in the projects.
- A strong business mindset is important to secure optimal output from our R&D activities.
- Be a role model for the team.
- You have experience in the Medical Device field accompanied with a relevant educational background.
- You have documented training within the Medical Device field. We expect you to have extensive experience working within the frame of e.g. ISO 13485, ISO 14971, FDA 21 CFR 820.30, MDR 2017/745 etc.
- Practical Project Management experience is prioritized over PM certification.
- You have a lot of drive – and you are comfortable in taking the lead in a project team.
- You thrive in delivering results – with respect for the processes we work with.
- You are comfortable working with the overall company goal as your objective – even if it compromises your project and short-term interests.
- You are structured – also in a dynamic environment with shifting priorities.
- You plan your own work and are comfortable guiding your colleagues to do the same.
- You are naturally positive with a go-do attitude
- You pay attention to your team and colleagues and prioritize overall success over personal gain. Respect and team spirit are key.
- You are pragmatic – always open for input and feedback, but firm on setting the bar correctly.
- You need to be flexible – solving the task at hand is key.
- You believe that success is easier (and more fun) as a team effort.
Language & IT
- Your level of English proficiency enables you to communicate clearly with all stakeholders – Danish and/or other languages are a bonus.
- You are comfortable using the MS Office programs – Word, Excel, PowerPoint
- Experience in, and being comfortable using, other relevant IT systems for documentation, planning etc. is expected
What we offer
- A dynamic work environment – within an ambitious and expanding enterprise.
- A workplace without a silo mentality – allowing you to engage in a broad variety of tasks if required.
- Short and fast decision making – and the responsibility that goes with it.
- Colleagues that expect you to do your best – and will help you do so.
- An international workplace – but with a solid base in Denmark.
- A strong relationship with our Polish production site – and the opportunity to engage with colleagues internationally
- Being part of a team that works in an exciting clinical environment offering a multitude of opportunities.
- Travelling is flexible and based on the need to achieve your goals, but you should expect 5 -20 travelling days pro anno.
Our department is LiNA Innovation and is currently staffed with 12 engaged colleagues and headed by the company CTO.
The Polish PTA department also refers to the CTO in LiNA Innovation and is as such also a part of LiNA Innovation. Currently staffed with 4 engineers.
LiNA Innovation primarily works with new product development and is responsible for the Technical file from project start through the submission process and until transfer. R&D also support the department taking care of the legacy products – but at a smaller scale.
Conditions and renumeration
An attractive base salary that matches your qualifications
- Full time employment (37 hours/week)
- Fixed monthly salary
- Pension and health insurance
- PC & phone
- Optional lunch plan
- 5 weeks annual vacation + 5 days individual vacation days
If you are interested in the position, please forward your application and CV to firstname.lastname@example.org, we look forward to hearing from you!