**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.** **Radiology Research and Early Development Technical Lead** **Radiology Research and Early Development Technical Lead** **PURPOSE** The position will be a technical leader in Radiology Research and Early Development organization to work on Fluid Delivery Systems compromising of Electro Mechanical systems, Sterile Disposable Configuration, Software and Accessories. The role will be responsible for managing broad range of all engineering activities primarily working with external partner company for research and development. This key role is accountable for realizing product vision by successfully bringing customer desires and business need into a working concept. The role will work with cross functional team to successfully demonstrate product feasibility, desirability and viability. **YOUR TASKS AND RESPONSIBILITIES** + As technical leader of the device program lead and manage cross engineering team which is responsible for to explore new ideas, product concepts, innovative features and new solutions for Radiology business with primary focus on Medical devices. The role will be responsible for leading the front end of innovation by understanding business strategy, customer needs and mapping those into realizable solutions; + The individual will play key role in developing strategic relationship with external design partner companies for rapid idea progression and early risk retirement activities. The role will provide leadership oversight specially focusing on technical feasibility and will be important information provider for analyzing concept viability and concept desirability. The role will engage with commercial and regional marketing to support business case development; + The individual will directly engage with physicians and clinicians (key opinion leaders, thought leaders,) as part of research and early development process; + The person will collaborate with regulatory and medical experts (internal, external) to define the strategy, scope and operational gameplan to ensure the product will successfully meet global regulatory requirements; + Initiate, develop, or maintain relationship with technical experts, and functional heads to resolve complex technical problem. Develop relationship with other program teams for lessons learned; + Plan and optimize and task with functional leads and program management to achieve desired program objectives and milestones. Careful and detailed technical planning to define and execute on project schedule is important; + Collaborate with Regulatory strategist to define the scope for submission dossiers and ensure the team deliverables are successfully meeting submission guidelines; + Work closely with internal or external manufacturing for successful industrialization of the design. As the leader of the technical team, ensure all design specifications are successfully transferred with internal or external production network and subsequently meeting the necessary product criterion for human use build. **WHO YOU ARE** Bayer seeks an incumbent who possesses the following: **REQUIRED QUALIFICATIONS** + B.S. degree in engineering, computer science, or related field; + Multiple years of experience in Phase 0-6 of Medical Device Development (Conception, Ideation, Requirements, Design, Verification, Validation, Launch); + Significant years of experience in core engineering disciplines including hardware, software, and processes; + Strong customer knowledge, procedure knowhow, product CTQ for Radiology Fluid delivery development system are necessary; + Leadership and motivational skills and ability to build functional teams through Matrix Organization; + Deep understanding of software and hardware development for medical devices; + Experience formulating and implementing product and market strategies on a global basis; + Significant experience and knowledge of global regulatory requirements associated with a Medical Devices company. **PREFERRED QUALIFICATIONS** + MS/PhD degree in engineering, computer science, or related similar field; + Over 5 years experience in Phase 0-6 of Medical Device Development (Conception, Ideation, Requirements, Design, Verification, Validation, Launch). + Over 7 years of Knowledge of global regulatory requirements associated with a Medical Devices company 7-10 years; + 10(BS), 8(MS), 6(PhD) years of experience in core engineering disciplines including hardware, software, and processes; + Over 7 years of knowledge of global regulatory requirements associated with a Medical Devices company. **YOUR APPLICATION** Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer. To all recruitment agencies: Bayer does not accept unsolicited third party resumes. Bayer is an Equal Opportunity Employer/Disabled/Veterans Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below. Bayer is an E-Verify Employer. **It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.** **Location:** United States : Pennsylvania : Indianola **Division:** Pharmaceuticals **Reference Code:** 839804 **Contact Us** **Email:** hrop_usa@bayer.com **Job Segment:** Medical Device, Radiology, R&D Engineer, Computer Science, Healthcare, Research, Engineering, Technology