Process Technician – MedTech
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Are you highly experienced when it comes to design control and validation? And are you passionate about working for a company that significantly improves patients’ quality of life? Then this might be the right opportunity for you!
Reapplix – a Danish MedTech company – has established that one of the keys to successful wound treatment lies in the body’s own capacity to heal. The patented 3C Patch® System produces a personalized wound therapy on demand in a simple 20-minute process using a small sample of the patient’s own blood. Diabetic Foot Ulcers can be a serious consequence of diabetes and around 60% of all patients experience a wound that can be hard to heal. Reapplix aims to transform the treatment of diabetic foot ulcers and improve the quality of life for patients. 3C Patch® is clinically proven to significantly accelerate wound healing, nearly doubling the chance of healing, and improve wound reduction of hard-to-heal diabetic foot ulcers.
As their new Process Technician, you have the unique opportunity to become part of empowering and ensuring the success of an exciting growth journey. You will play a key role, continually developing and improve the design control, validation of process and equipment and thereby support significant business growth, in a company where ambitions are immense, and the technology is state of the art.
As Process Technician, you will be working closely with stakeholders within development and operations and the rest of the organisation to ensure full alignment between business needs, suppliers, development and quality requirements. Therefore, you need to have a genuine interest in setting up and developing best-in-class processes and documentation for the manufacturing.
You will manage and contribute to different projects and ensure a smooth transition from development to manufacturing. This includes the documentation and validation that is required for these types of Medical Devices that will be sold globally, although US is the key market at this point. The scope of this potion is likely to expand over the coming years depending on the strategy. You will report directly to Chief Operation Officer, Carsten Heinze.
Your tasks will include, but not be limited to, the following:
To succeed in this role, you have 3 to 5 years of experience with ISO 13485 within medical device or pharma positions. You have a technical background for example mechanical engineer, production technician, validation technician or similar. Due to the nature of the Reapplix business, we prefer that you furthermore have solid experience with writing documentation and have a good understanding of manufacturing and the related processes including specification and validation of manufacturing equipment.
You know what it requires to build a solid relationship with your internal and external stakeholders, and at the same time be very structured in everything you do while meeting deadlines and maintaining pace. Further, you enjoy working in a scaleup company, heading towards something tremendous, and have the drive and passion to take on the responsibility of engaging in and ensuring the future success of Reapplix. Moreover, you should have an excellent command of both written and spoken English and a high level of IT skills.
The recruitment process is carried out in collaboration with the consulting company Compass Human Resources Group. If you want to learn more about this position before submitting your application, please do not hesitate to contact Research Consultant Mai Rishøj Madsen or Director Christian Winther on telephone +45 70 20 12 75. Please submit your application and CV as soon as possible, if you are interested. Applications will be processed on an ongoing basis. Please note that all enquiries will be handled with confidentiality and that we will reply to the email address from which you send your CV.
Reapplix has established that one of the keys to successful wound treatment lies in the body’s capacity to heal – and each patient is central to that process. Founded in 2008, Reapplix specialises in the biological treatment and management of diabetic foot ulcers. The patented 3C Patch® System is an innovative, evidence-based biological wound therapy made entirely from the patient’s own blood – nothing else. Headquartered in Denmark, with sales and distribution teams in the US and Europe. Reapplix won the 2018 EY Entrepreneur of the Year Award in the life science category.
Deadline for application: As soon as possible
Workplace: Denmark
Reference: 2218.059
Company: Reapplix ApS
Process Technician - MedTech
Reapplix ApS
Are you highly experienced when it comes to design control and validation? And are you passionate about working for a company that significantly improves patients’ quality of life? Then this might be the right opportunity for you!
Reapplix – a Danish MedTech company – has established that one of the keys to successful wound treatment lies in the body’s own capacity to heal. The patented 3C Patch® System produces a personalized wound therapy on demand in a simple 20-minute process using a small sample of the patient’s own blood. Diabetic Foot Ulcers can be a serious consequence of diabetes and around 60% of all patients experience a wound that can be hard to heal. Reapplix aims to transform the treatment of diabetic foot ulcers and improve the quality of life for patients. 3C Patch® is clinically proven to significantly accelerate wound healing, nearly doubling the chance of healing, and improve wound reduction of hard-to-heal diabetic foot ulcers.
As their new Process Technician, you have the unique opportunity to become part of empowering and ensuring the success of an exciting growth journey. You will play a key role, continually developing and improve the design control, validation of process and equipment and thereby support significant business growth, in a company where ambitions are immense, and the technology is state of the art.
Responsible for validation and processes from development to manufacturing
As Process Technician, you will be working closely with stakeholders within development and operations and the rest of the organisation to ensure full alignment between business needs, suppliers, development and quality requirements. Therefore, you need to have a genuine interest in setting up and developing best-in-class processes and documentation for the manufacturing.
You will manage and contribute to different projects and ensure a smooth transition from development to manufacturing. This includes the documentation and validation that is required for these types of Medical Devices that will be sold globally, although US is the key market at this point. The scope of this potion is likely to expand over the coming years depending on the strategy. You will report directly to Chief Operation Officer, Carsten Heinze.
Your tasks will include, but not be limited to, the following:
- Validation of process and manufacturing equipment, both internally and externally including documentation.
- Optimizing the existing manufacturing equipment and related processes.
- Project manage different projects – internal and external.
- Make sure that equipment and process are transferred from development to manufacturing in a structured way and documented accordingly.
- Design control including writing the documentation.
Structured approached and strong documentation skills
To succeed in this role, you have 3 to 5 years of experience with ISO 13485 within medical device or pharma positions. You have a technical background for example mechanical engineer, production technician, validation technician or similar. Due to the nature of the Reapplix business, we prefer that you furthermore have solid experience with writing documentation and have a good understanding of manufacturing and the related processes including specification and validation of manufacturing equipment.
You know what it requires to build a solid relationship with your internal and external stakeholders, and at the same time be very structured in everything you do while meeting deadlines and maintaining pace. Further, you enjoy working in a scaleup company, heading towards something tremendous, and have the drive and passion to take on the responsibility of engaging in and ensuring the future success of Reapplix. Moreover, you should have an excellent command of both written and spoken English and a high level of IT skills.
Apply for this exciting position at Reapplix
The recruitment process is carried out in collaboration with the consulting company Compass Human Resources Group. If you want to learn more about this position before submitting your application, please do not hesitate to contact Research Consultant Mai Rishøj Madsen or Director Christian Winther on telephone +45 70 20 12 75. Please submit your application and CV as soon as possible, if you are interested. Applications will be processed on an ongoing basis. Please note that all enquiries will be handled with confidentiality and that we will reply to the email address from which you send your CV.
About Reapplix:
Reapplix has established that one of the keys to successful wound treatment lies in the body’s capacity to heal – and each patient is central to that process. Founded in 2008, Reapplix specialises in the biological treatment and management of diabetic foot ulcers. The patented 3C Patch® System is an innovative, evidence-based biological wound therapy made entirely from the patient’s own blood – nothing else. Headquartered in Denmark, with sales and distribution teams in the US and Europe. Reapplix won the 2018 EY Entrepreneur of the Year Award in the life science category.
Deadline for application: As soon as possible
Workplace: Denmark
Reference: 2218.059
Company: Reapplix ApS
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Hele Danmark
Jobbet er oprettet på vores service den 21.2.2022, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
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