Design Control Specialist, Medical Devices

Location: Copenhagen, Denmark

Li NA Medical is looking for a Design Control Specialist with an engineering or similarly relevant background. You have solid experience with working in the crossing between RA – R&D – QA and are comfortable ensuring compliance in the teams’ projects where the focus will be on Design Control. The position will also encompass related areas of responsibility such as supporting work with CAPA, implementing new standards, and participating actively in audits.

Status: Out of date
Department: R&D

Responsibilities

Together with the Project Manager and the rest of the team you will be responsible for ensuring the quality of the documentation in the project. The main focus is compliance with external requirements, ensuring that the projects are continuously in compliance with the regulatory equirements
You will be responsible for driving your own job tasks, and together with the Project Manager you will further be responsible for ensuring that the rest of the team are aligned with the creation of the technical file. Together with the entire R&D organization you will be responsible for ensuring that Li NA Medical’s procedures for development are continuously up-to-date and effective. This requires insight into the use of relevant regulatory standards within Med Tech as well as solid experience with Design Control.

Key tasks / success criteria

Preparing Design Control documentation in new projects.

• Handling Risk Management processes including sound experience with ISO 14971.
• Completing documentation necessary for effectively achieving relevant approvals for marketing new products.
• Preparing test protocols and reports for V & V when needed.
• The position will give you the chance to participate in testing finished products and prototypes when this is required for the projects.
• Handling both departmental and organizational tasks, i.e., audit and maintenance of our QMS.

Professional qualifications

You have an engineering degree or similar technical background.

• You must have sound experience from Med Tech as well as from work with Design Control in projects (in an R&D or RA position).
• Thorough knowledge is expected of:
  • The new MDR, e.g., through implementation
  • ISO 13485
  • FDA 21 CFR 820
  • ISO 14971
• Experience with Risk Management in Medical Devices is an advantage.
• Experience with design input/output and V&V is an advantage.
• Experience with Design Control is a requirement.
• Experience with the clinical aspects of product development is an advantage – i.e., validation, user driven innovation or participation in clinical evaluations.
• Experience with document control systems is expected.

Personal characteristics

• 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, Power Point.
• 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 it is 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

Li NA Innovation

Our department Li NA Innovation is currently staffed with 12 engaged colleagues and headed by the company CTO.
The Polish PTA department also refers to the CTO in Li NA Innovation and is as such also a part of Li NA Innovation. Currently staffed with 4 l engineers.
Li NA 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
• Internet connection
• 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 hk@lina-medical.com, we look forward to hearing from you!