R&D Engineer for Chemical & Physical Analysis of Medical Devices

R&D Engineer for Chemical & Physical Analysis of Medical Devices

Placering
Osted
Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Group revenues in 2022 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com

Change is everywhere at Convatec. It’s transforming our business, and helping us improve millions of lives. And we’re nowhere near finished. Across every part of our business, we’re pushing for better. Join us on our journey to #ForeverCaring as an R&D Engineer, and you’ll do the same.

Are you passionate about characterizing and testing chemical interactions between polymers, steel, and medications? Do you thrive in a data-driven environment, that sustains state-of-the-art and EU MDR? Do you see yourself in a Global medical device company that is delivering the world’s best and most reliable infusion set for the treatment of chronic diseases such as Pain, Diabetes, and Parkinson’s Disease? Then consider applying for the position as Subject Matter Expert (SME) in Drug & Device Compatibility in our Medical Device Reliability department at Convatec Inc. Infusion Care.

Convatec inc. is a global medical device company that develops and manufactures class II and III products within ostomy, wound care, continence, and subcutaneous infusion. We are following our promise towards patients and healthcare providers of forever caring, that means that we strive for ultimate mechanical design, state-of-the-art chemical analysis and physical tests, and the development of highly innovative products.

The Department:

You will be part of the Medical Device Reliability department, which is one of 5 departments in the R&D organization. You will work with ten Test Engineers and two Test & Laboratory Assistants constituting a diversity of knowledge and qualifications. We are a dynamic team with international experience in a multi-cultural organization. We offer a hybrid workspace with a work location in Osted, near Roskilde, with the flexibility to work out of our Søborg office or from home up to 3 days a week. Convatec inc. is involved in B2B and B2C projects, and the department is collaborating with both internal and external stakeholders.

About the role:

As our Subject Matter Expert (SME) in Drug & Device Compatibility, you will be assuring that new and existing drugs are compatible with our products.
You will be working with the development of new test methods for testing chemical and physical compatibility between drugs (Biologics or small molecules), steel, and polymers used in our devices in accordance with state-of-the-art. You will drive compliance by working with the validation of test methods and related equipment.

You will utilize the developed test methods in projects, to assure compatibility between specific drugs and devices. Weekly, you will coordinate and participate in physical testing with the internal laboratory in Osted, and coordinate chemical testing with our internal laboratory in Deeside in Wales and external suppliers.

Your closest collaborations will be with our Product Quality Engineers, Quality Assurance Engineers, Mechanical Engineers, and Clinical and Biocompatibility specialists.

You will be responsible for data analyses and reporting of results, as well as communicating results. Additionally, you will use your expertise to support different teams within Business Development, Product Development, Sustaining Engineering, and Quality Assurance. The drug and device compatibility SME is a central role in an exciting company in constant growth.

Key responsibilities:

• Develop and maintain data on chemical and physical compatibility between relevant drug ingredients, steel, and polymers.
  • Drive compliance documents such as procedure updates related to Drug and Device compatibility.
  • Plan, coordinate, and review tests of new product designs for design verification and stability studies.
  • Participate as a Drug & Device Compatibility SME in business development, product development projects, feasibility studies, quality audits, and alike.

#LI-MF1
#LI-Hybrid

This is work that’ll move you.

This is a big step forward.

Our progress will give you countless opportunities to move forward too. Seek out new challenges, and you’ll find them. Stretch your thinking, and you’ll find new ways to make an impact. And if you embrace the opportunity to drive your own growth, you could go further, and achieve more, than ever before.

Our ambitions will bring the very best out in you. You will be pushed to aim higher and own your work. You will be encouraged and supported to make things happen, too. It can be challenging. But, as the progress you make will help improve the lives of millions, it will be worth it. Interviews will be conducted continuously, so we encourage you to submit your application as soon as possible. In case of questions about the position, please contact Kim Schüsler, Associate Director, Medical Device Reliability, by cell phone at +45 2926 5809. We look forward to receiving your application, CV, and other relevant documents.

We offer you a position in a dynamic and global company with great benefits and flexibility for the employees and where the days are never the same. Convatec will provide you with challenges and development opportunities and the chance to influence your role. You will be a part of a great community where we all help and support each other – while continuously building on our competencies and network. We will provide you with courses and training to strengthen your competencies to deliver the best results.

About us

You can expect about 10 travel days annually.

Travel requirements:

The primary workplace is in Osted, Denmark. We offer a hybrid workspace, with the possibility of working out of our Søborg office or from home when it fits your tasks.

Location:

• You have experience and knowledge within Medical Devices or Pharma development.
• You have a material understanding of polymers, steel, and drug interactions.
• You have experience with the validation of methods according to EU ISO 13485, US 21CFR820, or similar regulations.
• You have knowledge of statistical analysis like ANOVA, T-test, GR&R, P/T ratio, DOE using SAS JMP, Minitab or alike.
• Further knowledge of US and European standards will be an advantage.
• You have excellent written and verbal communication skills in English.

We expect you to have a master’s or bachelor’s degree in STEM or a similar technical diploma, with at least 3 years of relevant experience.

Qualifications:

You are a team player with a holistic mindset. You utilize your good collaboration skills to work with colleagues from other departments. You are pragmatic and operate with a sense of urgency to meet deadlines. You enjoy a dynamic workday and can progress several tasks in parallel in a dynamic environment.
You understand the importance of good documentation practices and see the value in creating solid documentation of test methods and supporting documentation.

You will bring investigative, analytical, and technical knowledge, skills, and experience in the field of chemical and physical characteristics of polymers and their interaction with medical drugs or similar solvents. Experience with stability studies of drugs, test method validation of physical, chemical, and/or biological test methods, biocompatibility, computer simulations, or process improvement techniques like Lean Six Sigma will be an advantage.

About you: