- Participate in product maintenance projects in collaboration with QA, sourcing, and manufacturing.
- Plan modification and validation of fixtures and test methods including operator training.
- Plan and coordinate test of changed product designs for design verification and stability studies.
- Transfer of test methods to manufacturing sites in Osted and Reynosa, when required.
- Training and coaching of colleagues in changed test methods.
- Carry out and review design verification documentation, , design verification plan, protocol, report, and test method transfer, along with detailed equipment user instructions and test procedures.
- Occasional participation in the processing of CAPA's and NC's, comprising root cause analysis, test method changes, documentation, and training.
- Master's or bachelor's degree in engineering, physics, pharmacy, technical science, or similar technical diploma, with at least 3 years of relevant experience.
- Experience in design verification, and validation of methods in the medical device industry, in accordance with EU ISO 13485, US 21CFR820, MDR, and MDSAP.
- Knowledge of statistical analysis like ANOVA, T-test, GR&R, P/T ratio, DOE using SAS JMP, Minitab, or alike.
- Knowledge of Medical Device product development (Class II) will be an added value.
- Knowledge of regulatory legislation and standards will be an added value.
- You have excellent written and verbal communication skills in English and Danish.
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Test & Reliability Engineer - Sustaining Engineering, Medical Devices - Osted, Danmark - ConvaTec
Beskrivelse
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 visitDo you have a keen eye for Physical Testing, Product Quality, Reliability, Validation, and Documentation? Are you looking for an opportunity to merge your passion with our expertise in the Test and Verification of Infusion Care Medical Devices, for the treatment of chronic diseases such as Diabetes and Parkinson's Disease? Will you support the development of innovative products that improve people's lives? Do you want to join a world-leading company in growth?
Every day, our products improve the lives of millions of people around the world, and we are in an exciting period of transforming our business to reach millions more. Join us as a Test Engineer in our Sustaining Engineering (SEG) team.
About the role
As a Test Engineer, you will be involved in developing and working with a diversity of physical test methods. Planning and coordinating tests in our laboratory in Osted near Roskilde, and partners within Global Convatec and external. Most of your time, you will be part of a project team in SEG.
As part of SEG Team, you will have the responsibility for preparing, executing and documentation of tests, performed on existing or changed products already available on the global market. This involves planning and coordination of design verification with the R&D Laboratory in Osted and Manufacturing sites in Osted and in Reynosa, Mexico.
You will work in a dynamic team with international exposure in a multi-cultural organization. You will be part of an inclusive team of nine proficient Test Engineers constituting a diversity of qualifications two highly skilled Test Assistants, and a Student Assistant. You will report to the Associate Director of Medical Device Reliability in Infusion Care R&D, based in Denmark.
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.
Key Responsibilities
About you
You will bring the technical knowledge, skills, and experience in physical testing, statistical analysis, and documentation or alike to further proficient our MD Reliability and SEG teams. Experience with test method validation of physical, chemical and/or biological metrics, fluid flow, test and analysis automation, computer simulations, or process improvement techniques like Lean Six Sigma will be an added value.
Besides having a solid physical testing and documentation foundation, you are a distinct team player with a holistic mindset. You utilize your good collaboration skills to work with Mechanical Development, Process Engineering, Manufacturing, QA/QC, and Regulative Affairs. You are pragmatic and operate with a sense of urgency to meet your deadlines. You enjoy a busy working day and can progress several tasks in parallel, thriving with evolving, changes and various tasks.
You understand the importance of good documentation practices and see the value in creating solid validation documentation of design verification, test methods, and supporting documentation.
Qualification
Working Conditions
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.
Travel requirements
You can expect about 10 travel days annually.
About us
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 own 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.
Interviews will be conducted continuously, so we encourage you to submit your application (in English) as soon as possible. In case of questions about the position, please contact Kim Schüsler, Associate Director of Medical Device Reliability in Infusion Care R&D, at cell phone We look forward to hearing from you
You do not need to attach a cover letter to your application, but please include your motivation for applying for the job in your CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo to your CV.
At Convatec, our vision is to develop pioneering trusted medical solutions to improve the lives we touch. We devise, develop, and manufacture innovative products and services that support people with deeply personal and challenging medical conditions, helping to improve care for them and giving them greater confidence, freedom, and mobility.
Convatec, Infusion Care (Unomedical a/s) is part of a global medical technology business focused on serving people and caregivers. We develop and market sterile disposable products for subcutaneous infusion of various medications. Specialized in the treatment of chronic diseases, such as Diabetes Mellitus and Parkinson's Disease. Our manufacturing facilities in Denmark and Mexico produce more than 100 million infusion sets per year, making us the world leader in this field. Further information about the company can be found at our website
Our transformation will change your career. For good. You'll be pushed to think bigger and aim for excellence. Your ideas will be heard, and you'll be supported to bring them to life. There'll be challenges. But stretch yourself and embrace the opportunities, and you could make your biggest impact yet.
This is stepping outside of your comfort zone.
This is work that'll move you.
#LI-MF1
#LI-Hybrid
Beware of scams online or from individuals claiming to represent Convatec
A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.
If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you're unsure, please contact us at .
Equal opportunities
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
