Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees in 67 countries work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions.
Your role:To be responsible for providing technical design expertise in the development of our leading-edge Drug Delivery medical devices throughout the execution cycle from early stage concept evaluation, through requirements definition to product filing and market launch. You will contribute technically in cross-functional project teams by proposing device concept solutions and lead feasibility studies in collaboration with relevant external supplier and design consulting companies to ensure timely delivery of the required functionality, process equipment, testing methods within set budget and with compliance to quality, regulatory & customer requirements. You will have a strong technical curiosity and good understanding of the latest industry, technology and design techniques to bear on our projects. You have a bias for action and can break down complex problems into steps that drive product development.
As a technical expert, you will play a key role in the delivery of Merck’s medical device solutions.
Who you are:
- A passionate desire to help improve the lives of people living with chronic diseases.
- Degree (or equivalent) in Industrial design, Mechanical Engineering, Materials Science or Electronic/Software Engineering field.
- At least 5 -8 years of experience in medical device design, development and test including project and supplier management.
- Experienced in leading the technical selection of secondary packaging/device sub-systems for drug delivery product types, e.g. Auto injectors, Pen injectors, infusion systems, needle free systems, inhalers, patch pumps etc.
- Experience in 3D CAD modeling, FEA analysis, theoretical analyses, calculations & prototyping activities as well as a hand-on approach for evaluating the same prior to scaling up for mass production.
- Experience in Design of Experiments, prototyping design concepts and in reaching robust design conclusions
- Expertise in root cause analysis and FMEA.
- Good understanding of material science, molding technologies and bespoke manufacturing processes applicable in the design, development and release of medical devices and combination products in mass production.
- Work in collaboration with the Merck drug formulation team, Equipment engineering team & the process development team to develop appropriate internal equipment to fill & complete assembly of the devices to form the final drug product.
- Demonstrable experience and applicable expertise in requirements gathering, product specifications, design of medical devices including interoperability with external applications and other 3rd party components.
- Experience in the development of test methods, structures and the qualification and tech-transfer of these to mass production.
- Experience with the following standards and directives is an asset EN60601, 21 CFR 820, IEC 62304, FDA guidelines, MEDICAL DEVICE COUNCIL DIRECTIVE 93/42/EEC, ISO 13485 and ISO 11608
- To develop and maintain an effective network of external experts and contractors that can be used to successfully deliver on Merck’s medical device development plans.
What we offer:Your possibilities to develop in our growing company are just as manifold as our product portfolio. We offer a modern and international working environment to unleash your innovative potential in diverse teams, and take responsibility for our employees, products, the environment and society.
Curious? Apply and find more information at come2merck.com