Description

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!

 

As the Sr Engineering Project Manager (PM) for the Impella ECP platform you will make significant contributions towards Abiomed's next generation of heart pumps. The role is responsible for key engineering project deliverables while managing project scope, budget, and timeline. The Sr PM is responsible for reviewing and reporting on the overall program and making technical decisions with support staff.  Understanding the technical activities within the project, early identification of risks and their mitigations, and maintaining critical path are key criteria for the position. 

Our team is dynamic and has far ranging technical engagements. We are looking to add a versatile, eager-to-learn, and driven individual to own and collaborate on design initiatives. You will have a tangible impact on the business and on improving patient care.  

Principal Duties and Responsibilities: 

• Manage complex design and development projects on novel hemodynamic support devices 
• Establish design goals and specifications based on requirements and user needs. 
• Transform clinical observations into new device concepts or approaches 
• Bring solutions to market by collaborating with an exceptional cross-functional team 
• Work with internal and external manufacturing partners to ensure producible designs (DFM) within an aggressive timeline 
• Develop and set interim goals and milestones to ensure overall project success  
• Address technical and programmatic risks, ensuring effective risk identification, assessment and mitigation. 
• Prepare and present design reviews to ensure the technical integrity of the product design. 
• Prepare and present management reviews to effectively communicate cross-functionality the project issues, risks, and timing of the product. 
• Work with engineering team to ensure timely and complete DHF / design control deliverables. 
• Suggest and contribute to initiatives that improve the Engineering Department’s operations and procedures. 

Qualifications

Job Qualifications: 

• BS in Mechanical, Biomedical Engineering or directly related scientific discipline. 
• 7+ years experience leading and executing the coordination of programs/projects and the delivery of products in engineering/R&D teams. Exceptional project coordination skills while being able to multi-task and meet multiple project schedules on time. 
• Successful completion of a medical device development project from concept to launch. Expert in understanding design controls and deliverables. 
• Exceptional project coordination skills while being able to multi-task and meet multiple project schedules on time. 
• Strong verbal and written communication, analytical/problem solving, negotiation, and interpersonal skills. 
• Ability to understand and apply applicable FDA regulations and company operating procedures, processes, policies, and rules. 
• Familiarity presenting on and explaining projects at all levels of the organization. 
• Team oriented.  Proven teamwork skills in a cross-functional engineering environment, ability to motivate and empower team members, set and manage expectations. 
• Committed to being patients first and responsive to unmet needs. 
• Experience and ability interacting with FDA and other regulatory agencies. 
• Proficiency with project budgeting and forecasting, MS PowerPoint, Project Management softwares, MS Excel. 
• 10% Travel (project dependent)  

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.