Research & Development/Sciences
Phillips-Medisize, a Koch Company, is building solutions in partnerships with global biopharmaceutical companies to service the expanding need for self-administrated drug delivery devices suitable for especially liquid injectable drugs. To support this growing market with faster timelines to market combined with reduced development risks, several different medical device product platforms are currently in development to provide customers with a head start for launching new drugs.
Do you want to design safe and reliable medical devices, bringing our clients’ life-changing solutions into the hands of patients and helping patients to get better treatment?
Then join us and work together with your highly skilled colleagues to bring new products to market in a fast-growing and successful global company!
We are currently hiring a
Risk Engineer (m/f/d) – Medical Device Development
fulltime, in Struer or Virum, DK (hybrid working model)
What You Will Do in Your Role
- Conducting Risk management in compliance with EN/ISO14971:2019, MDR, and Phillips-Medisize myQMS.
- Planning, leading, and reporting Risk Management activities
- Thorough documentation using the FMEA Med8 tool and templates.
- Communication with internal and external stakeholders (clients)
- Facilitating close collaboration with the project team members within risk-related areas
- Getting a deep cross-functional technical understanding of the product
- Contribute to continuous improvement and lessons learned.
The Experience You Will Bring
- Master’s or bachelor’s Engineering degree or similar
- Experience from working with risk management in a highly regulated industry
- Experience and skills in writing, reviewing, and maintaining documentation
- Strong teamwork capabilities and ability to take lead on workstreams
- Great communication skills
- Self-motivated having a persistent drive to plan and execute
- Full professional proficiency in English
What Will Put You Ahead
- Experience in the Medical Device Industry
- Familiar with Medical Device Development and Design Control
- Knowledge and understanding of ISO14971 and MDR
- Experience with IEC 62304
- Experience working with R&D cross-functional teams and clients
If you are interested in this role or know someone who would be a good fit, please reach out to me ([email protected]) or apply directly through the link. We are looking forward to your application!