Engineer II, Pkg

at  Boston Scientific Corporation

Work mode: Hybrid
Onsite Location(s):Coyol, CR
Additional Locations: N/A
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.
Hybrid Roles:
Boston Scientific’s hybrid workplace includes onsite. You will have the opportunity to discuss details in the interview

ABOUT THE ROLE:

Responsible for the coordination and development of the packaging process as well as the supporting functions for review and approval of specifications, artwork, and content. Works to assure all labeling and packaging components are correct and follows applicable regulatory requirements (EU MDR).

YOUR RESPONSIBILITIES INCLUDE:

• Works cooperatively with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, Supply Chain, and Marketing to ensure project success
• Creation and development of packaging processes fulfilling process outputs per product specifications, for example but not limited to, manufacturing documentation, process validations or verifications (MES Docs, GOIs, Process Plans, PC, TMV, OQ/PQ).
• Support packaging and labeling components development teams for review and approval of specifications, artwork, and content.
• Responsible to conduct process change assessments evaluating potential impacts for the production line as well as the mitigation plan.
• Work with the EU MDR project team to understand and planning required activities ensuring to meet critical dates aligned with business strategies.
• Prepares standard reports/documentation to communicate results to the technical community (PRB, CCB).
• Train product builders on new process and/or test procedures.
• Responsible to understand, evaluate and perform any risk management documentation change related with packaging and labeling processes.
• Communication and alignment with multiple production/business units simultaneously to conduct and implement EU MDR projects.
• Execute packaging and labeling required testing to ensure proper performance for equipment and components.
• Responsible to configure, implement and give support on activities related to Global Labeling System according with business requirements.