Job Description :
Qualifications:
Business acumen
Role model of Vital Behaviors and Leadership Essentials
Expertise in all aspects of program management
Knowledgeable in all aspects of developing consumer targeted medical device software products (web based and mobile applications Deep knowledge in medical device product requirement generation, software product development processes (SDLC), Verification, and Validation to comply with international medical device regulatory requirements.
Has to be able to assess validity of overall program/project strategy and deliverables
Must have understanding of product and functional processes to adequately assess project risk and challenge functional planning content
Understanding of Good Manufacturing Practices, Good Laboratory or Clinical Practices and Product Development Process requirements
Clear understanding of 21CFR 820, ISO 13485, ISO 14971, IEC 62304
Demonstrated ability to supervise and develop others

Education and/or Experience:
A minimum of an MBA/MS or Bachelor''s in Mechanical, Electrical or Biomedical (least ideal) with equivalent plus 7 years Global, multi facility project management experience
10 years of product life cycle experience with demonstrated success leading multi-site, global or enterprise- wide programs in the biotech/pharmaceutical industry
PMI or IPMA or equivalent certification desired
MS Project required