**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.** **Device Design Engineer for Sterile Disposables** **Device Design Engineer for Sterile Disposables** **PURPOSE** The Device Design Engineer for Sterile Disposables will lead a range of design and testing efforts pertaining to the development and sustenance of innovative plastic sterile medical disposable products. **YOUR TASKS AND RESPONSIBILITIES** + Provide full lifecycle engineering support for sterile disposable (SD) product designs utilized in radiology and cardiovascular medical procedures; + Support general engineering topics (mechanical, labeling, etc.) for device designs as needed; + Design, conduct, execute and direct testing within the development lab environment to verify product design changes; + Investigate and remediate design-related product issues discovered during verification testing, by customers, and during routine production; + Research and develop new technologies associated with medical products; + Author and maintain detailed product requirements and design outputs; + Maintain design history file documentation throughout the product development and change process including technical assessments, test protocols / reports, and various forms of other engineering documentation; + Apply knowledge of plastic materials and a broad portfolio of manufacturing processes such as extrusion, bonding, molding, packaging, distribution and sterilization; + Lead small teams on lower complexity project activities; + Lead design reviews and participate in other design reviews as a reviewer; + Write scientific protocols, manage/perform the execution of the protocols, analyze results, and write reports; + Interface with authorities and auditors for product design-related topics and inquiries; + Collaborate with stakeholders to initiate and execute projects in a highly effective manner, delivering maximum value; + Communicate effectively with a diverse range of internal and external stakeholders to gather input and provide updates on project planning and execution. **WHO YOU ARE** Bayer seeks in incumbent who possesses the following: **REQUIRED QUALIFICATIONS** + Bachelor’s degree in mechanical, biomedical, and/or plastic engineering with a minimum of 2 years of full-time relevant work experience; + Prior experience in medical device manufacturing industry; + Familiarity with lab equipment and methods used during the verification of SD and mechanical designs; + Experience leading small teams, demonstrating a collaborative leadership style; + Ability to initiate and execute complex projects by leveraging cross-functional relationships; + Strong analytical abilities with a strategic approach to resolving issues; + Effective verbal and written communication skills; + Ability to navigate change and ambiguity while considering different organizational perspectives. **PREFERRED QUALIFICATIONS** + Familiarity with a variety of applicable standards (ISO-13485, ISO-11607, ISO-10993, ISO-11137, ASTM 4169, etc.); + Familiarity with Regulatory, Quality, Procurement, and Risk Management. **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:** 839980 **Contact Us** **Email:** hrop_usa@bayer.com **Job Segment:** Biomedical Engineering, Medical Device Engineer, Design Engineer, Manufacturing Engineer, Medical Device, Engineering, Healthcare