Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Principal Engineer Devices & Combination Products (m/f/d)
YOUR TASKS AND RESPONSIBILITIES
- Builds strong organizational technical capability for current and future product portfolio needs related to Medical Device & Drug-Device Combination Product technologies (e.g. Inhaler & Nebulizer, Re-Usable & Disposable Auto-Injectors, Wearable Injection Systems, Pre-filled Syringes, Smart Devices / Connectivity)
- Leads technical capability integration of Medical Device & Drug-Device Combination Product technologies to support Pharma product portfolio (e.g. stand-alone Medical Devices, single-entity / co-packed / cross-labelled Drug-Device Combination Products)
- Serves as technical expert in PS Product and Project teams and as an interface between R&D and PS teams for assigned product portfolio to ensure smooth Design Transfers, robust manufacturing processes and that current technology considerations are leveraged for life cycle engineering activities
- Leverages mechanical engineering expert knowledge of Medical Device & Drug-Device Combination Product technology including experience in product development (Design Control principles), manufacturing processes (e.g. final devices, sub-assemblies, injection molding, tooling) and material science (e.g. rubber, polymers, and glass) and functional physical testing for final products to influence innovative product portfolio and anticipate foreseeable technical challenges.
- Executes across assigned product lines ensuring alignment of technologies for manufacturing process at all stages of the commercial life cycle in collaboration with key stakeholders
- Serves as key technical expert in resolution of any manufacturing issues related to assigned product portfolio in partnership with internal and external manufactures and life cycle engineering
- Effectively communicates complex technical issues related Medical Device & Drug-Device Combination Product technologies to broad and diverse stakeholders
- Effectively manages project portfolio and independently prioritizes complex portfolio with appropriate risk mitigation
WHO YOU ARE
- Master’s degree in Engineering, Technical or relevant field required
- Long-term work experience in pharmaceutical / medical device industry (drug-device combination products, technical leadership experience in project or functional management roles, technology / process / design transfers to manufacturing plants from development or other manufacturer, process validation, technical services, manufacturing, product development, multiple medical device & drug-device combination product functions preferred)
- Strong GMP and medical device & drug-device combination product regulation knowledge required (e.g. 21 CFR part 820, ISO 13485, ISO 14971, ISO 60601, ISO 11608, ISO 11040)
- Knowledge of key technologies, such as assembly (manual & automated), labeling & packaging, injection molding & tool design, sterilization
- Flexible open to new ideas and technologies
- Demonstrated ability to drive for results and lead innovation and change
- Project management skills with the ability to motivate and manage a team within a matrix organization
- Six Sigma training and certification preferred (green and / or black belt, lean, design for six sigma)
- Required proficient in the English language, both written and verbal; German desired but not mandatory
- It is important that you are self-motivating and work structured
Are you looking for a new challenge where you can show your passion for innovation? Are you interested in working as part of a global team to improve people’s lives? Then send us your online application including cover letter, CV and references.
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Reference Code: 65407
Functional Area: Engineering & Technology
Entry Level : Professional