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Program Manager, Impella
Company: Abiomed
Job ID#: 81871
# of Positions: 1
Job Type: Full Time
Location: Danvers
Department: Engineering
Salary: Commensurate with Experience
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Job Description
ABIOMED is seeking a Program Manager for our Impella Program to manage multi-disciplinary teams in the design, development, and commercialization of single use medical implants and/or instrumentation while successfully meeting technical, schedule, quality and budget targets.
The ideal candidate will have worked with class III implantable devices, have strong design and materials skills, have programs that included pre-clinical and clinical trials and have demonstrated experience with design control spanning product definition, specification, design, verification, validation, and quality and manufacturing.
Specific duties include but are not limited to the following:
* Leadership/Planning:
- Participate in the creation of Program Proposals by defining project scope, schedule, risk assessments and budgets.
- Work closely with senior management to establish program milestones.
- Lead a multi-disciplinary team to coordinate efforts, identify risks and focus priorities to achieve program milestones.
- Develop and maintain annual budgets, program priorities and development goals.
- Communicate ideas and information clearly, effectively, and frequently (oral and/or written) within program team and throughout the company.
- Present weekly program progress updates.
* Management/Execution:
- Manage the staff and development efforts from the prototype phase and thru commercial release.
- Apply program management techniques to ensure technical, financial and schedule success.
- Manage coordination efforts with manufacturing, quality assurance, regulatory and other internal organizations.
- Prioritize task importance and maintain the project teams focus on critical issues.
* Technical Leadership:
- Possess a strong functional understanding of all aspects pertaining to the design, development and commercialization of disposable products.
- Strong working knowledge of FDA\'s QSR and practical application through, design control SOP\'s, verification and validation testing.
* Department Contribution:
- Suggest, contribute and/or champion initiatives to improve the execution of product development processes
Skills/Requirements
General Requirements:
* BS in Engineering (Mechanical, Biomedical, or Plastics; advanced degree a plus) with 10 years practical engineering experience, 5 years successful program management experience; medical device industry a plus.
* Previous experience is managing programs with clinical trials required.
* Project Management Certificate a plus.
* Six Sigma and Design for Six Sigma training a plus.
* Position requires 25% travel ? Most travel in EU

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