Senior Principal Device Design Engineer (m/f/d)

 

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

 

Senior Principal Device Design Engineer (m/f/d) 

 

Your tasks and responsibilities

• You will plan, coordinate and execute Design Development and Life Cycle Engineering activities to successfully bring new Medical Device & Drug-Device Combination Products to the market and continuously improve the marketed Bayer Product Supply Product Portfolio
• You will evaluate new and breakthrough technologies by applying theoretical engineering knowledge, to establish robust technical product requirements, and develop engineering design solutions to assure products maintain the required level of performance throughout the life of the product
• You will provide author technical documentation (e.g. Design Development Plans, User Requirements Specifications, Design Inputs, Design Outputs, and DHF creation/ maintenance of DHF documentation), conformity assessments and risk management documentation
• You will represent the design engineering team within global project teams and execute projects independently within the agreed time, quality, and cost constraints, resulting in state-of-the-art drug delivery systems
• You will actively offer technical consulting and manage the technical interfaces towards our internal and external development partners
• You will apply knowledge of the drug and medical devices regulatory landscape to ensure standard-compliant designs according to pharmacopeias (MDR, ISO 13485, 21CFR820, ISO14971, 21CFR820.30, ISO60601, ISO11608, ISO11040)
• You will ensure continuous improvement of our development and life cycle engineering processes
• You will act as a recognized as global Subject Matter Expert to drive independent multiple technical activities like design transfers, root cause analysis and technical registration documents
• You will mentor/support less experienced design team members in complex projects and general skill development

 

Who you are

• Bachelor’s degree in engineering or other science disciplines like pharmaceutical technology, mechanical engineering, pharmacy or equivalent required whereas Master’s degree in an engineering or scientific discipline is preferred
• Many years of work experience in the Medical Device & Drug-Device Combination Product industry (multiple Medical Device & Drug-Device Combination Product functions preferred, product development, new product introduction/ industrialization, design verification, design transfer)
• A few years of experience leading product development activities and projects
• Broad and deep understanding of a variety of applicable standards and regulations (e.g., 21CFR820, ISO-13485, ISO-11607, ISO-14971, ISO-10993, ISO-11137, ASTM 4169, etc.) is required
• Demonstrated experience at utilizing Design Control processes to develop, launch and sustain medical devices and combination products
• Experience with managing/coordinating the work of other internal and external design team members.
• Knowledge of multiple technologies, such as injection molding, tool design assembly (manual & automated), sterilization, labeling & packaging
• Familiarity with equipment, test methods and best practices applicable to the verification of product designs
• Strong quantitative and qualitative analytical background and skills to understand and interpret analytical results (e.g. dissolution testing, functional and physical testing)
• Good statistical background and very good IT skills (e.g., Excel, Minitab)
• Experience leading small teams, demonstrating a collaborative leadership style
• Ability to initiate and execute complex projects by leveraging cross-functional relationships
• Fluency in English and German

 

What we offer

Our benefits package is flexible, appreciative, and tailored to your lifestyle, because: What matters to you, matters to us! ​

 

• We ensure your financial stability through a competitive compensation package, consisting of an attractive base pay and our annual bonus. In addition, managers can recognize special contributions by