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Senior Packaging Engineer - Cincinnati Ohio
Company: Mammotome Location: Cincinnati, Ohio
Posted On: 01/26/2025
Mammotome associates know that every moment matters when it comes to advancing breast cancer diagnostics and surgical solutions. When you come to work at Mammotome, you're collaborating with a global team of engineers, designers, communicators, strategists, and specialists to improve patient outcomes. If you want to be inspired to grow every day, join our diverse, hardworking, high-performing team.Be part of a company that's a trusted leader in breast cancer diagnostics and support products you can feel passionate about!Mammotome is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges. The Senior Packaging Engineer for Mammotome is responsible for supporting the design, development, verification, and validation of packaging systems for Mammotome's medical device products.This position is part of the Engineering Department located in Cincinnati, Ohio and will be on-site. At Mammotome, our passion is driving innovative technologies that create efficiencies, while never forgetting that at the heart of every breast cancer journey is a patient.You will be a part of the Packaging Engineering and Labeling Team and report to the Packaging Engineering and Labeling Manager responsible for the development of sterile and non-sterile packaging systems. If you thrive in a multifunctional, fast paced role and want to work to build a world-class packaging and labeling organization-read on.In this role, you will have the opportunity to: - Packaging Project Support: Participate in packaging and labeling related projects by developing requirements, planning, designing, sourcing, and implementing packaging systems for sterile and non-sterile medical device products.
- Process Development: Contribute to the selection of manufacturing equipment and assist in process development, including IQ, OQ, PQ activities.
- Material and Technology Evaluation: Evaluate new packaging and labeling technologies and support line trials and packaging validation activities prior to the introduction of any new components/processes.
- Risk Management: Perform risk management activities within the quality management system by utilizing appropriate design controls.
- Verification and Validation Support: Support Verification and Validation (V&V) activities by working closely with the V&V team and external testing facilities.The essential requirements of the job include:
- Education: Minimum Bachelor's degree (BS) in Packaging or a related field
- Experience: 5+ years of packaging work experience with 3+ years of sterile medical device
- Regulatory and Technical Proficiency: Familiarity with Good Manufacturing Practices (GMPs), ISO regulations (ISO11607-1/-2 and ISO13485), and proficiency in material and packaging test methods (ASTM and ISTA) and sterilization processes
- Independent Work: Capability to work independently with minimal supervision and collaborate effectively with cross-functional teams Travel, Motor Vehicle Record & Physical/Environment Requirements :
- Must be able to travel up to 10% of the time; both domestic and international travel may be requiredIt would be a plus if you also possess previous experience in:
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