Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.

I Am Abiomed | I Am Heart Recovery | Patients First!

Abiomed is looking for a Product Engineer I to help lead the supply chain organization into the future. The ideal candidate will have a passion for figuring out how to leverage data to optimize supply chain performance and capabilities. They will partner with functional leads/SME’s, business stakeholders, and IT to interpret and shape solutions that are complaint, efficient, and scalable. This individual will lead optimization and effectiveness of the global supply chain business processes and systems including their design, architecture, configuration, and integration across the business. They will achieve this through their knowledge of best-in-class supply chain processes, systems subject matter expertise, and strong collaboration with process development, customer service, quality, manufacturing, finance, and IT.

Principal Duties and Responsibilities:

• Attend product development project meetings to define product / bill of materials structure for multiple configurations, and multiple countries
• Assess country/regions specific requirements and implement with product management and logistics teams
• Introduce new product configurations onto the production floor
• Timely implementation of configuration management strategy to ensure production/supply chain flow is not interrupted during introduction of new configurations
• Support 5S initiatives in new Supply Chain and Logistics facility
• Communicate project status, schedule progress and key project metrics through scorecard presentations, action items and meeting minutes, and manufacturing readiness reviews
• In conjunction with Production Engineering, develop process documentation (assembly procedures, routers, travelers, BOMs, process flows, and process FMEAs)
• Work with Production and Engineering personnel in multiple countries to ensure consistent supply of product
• Work with Product Management and Regulatory to ensure label and packaging configurations are appropriate for localized needs requirements. Support limited market releases for design evaluations
• Learn product labeling system and support new and updated labeling requirements (UDI requirements and application, CE marking for EU, and other requirements for various countries)
• Support the transfer of product improvements into production utilizing Design for Manufacturing (DFM) principles
• Learn requirements for environmental monitoring, maintenance of equipment and associated software
• Support requirements for product packaging definition, validation and testing
• Support sterilization requirements (routine, special, validations)

Required Qualifications:

• Bachelor's degree in Engineering
• 1+ years of experience with product configuration and label generation in a Manufacturing/Production/Logistics Engineering role
• Knowledge of packaging and labeling requirements
• Knowledge of pick-to-order (PTO), postponement, and warehouse strategies
• Knowledge of Process Capability
• Experience with data analysis using statistical tools
• Knowledge of sterilization principles
• Good demonstrated knowledge of 5S, Six Sigma, Lean and Design of Manufacturing
• Understanding of project management
• Demonstrated critical thinking in a fast paced environment
• Demonstrated ability to work well in a team environment while continually and constructively challenging the status quo
• Dedicated, passionate and eager to learn
• Willingness to travel up to 15% of the time, domestically and internationally

Preferred Qualifications:

• Medical device experience strongly preferred
• Six Sigma Green or Black Belt
• Knowledge of SAP
• Knowledge of configuration management

Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace.