Responsibilities
- Lead and motivate a cross-functional, hybrid agile team to successfully deliver compliance, supply continuity, and quality projects for a blood specimen collection product group.
- Work with Product Owners and SMEs to decompose a project backlog into a prioritized task backlog.
- Optimize value delivered to the organization by planning sprints from the task backlog taking care to plan backward from impact dates and ensuring alignment with organizational goals and regulatory requirements.
- Implement and champion agile project management methodologies to enhance project efficiency and adaptability.
- Foster a collaborative and sprint-oriented project environment, ensuring continuous improvement and responsiveness to changing priorities.
- Ensure proper phase-gate processes are followed for each project as well as drive the completion of all relevant Design History File and Change Control paperwork.
Position Requirements
Education/Experience
- BS degree in Mechanical Engineering, Materials Science Engineering, Biomedical Engineering or a closely related engineering degree is required. An advanced degree in an engineering discipline or MBA is preferred.
- Overall 10+ years of experience is mandatory.
- At least 8 years relevant experience in product development and design; experience in medical devices/products is a plus.
- Minimum of 5 years project management experience.
- Experience in medical device industries required, including experience in FDA or other regulated environments required.
- Exceptional analytical, critical thinking and problem-solving skills. Demonstrated learning agility of new subject matter.
- Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience.
- Ability to take disparate data points and make sound business decisions and bring clarity to ambiguous situations.
- Demonstrate leadership, learning agility and action orientation when facing uncertainty. Instill confidence through leadership and actions.
Licenses or Certifications
- Program Management Professional Certificate Preferred
Special Skills
- A Six-Sigma design and development background is preferred.
- Has successfully completed design change activities for medical devices.
- Experience developing Class II medical devices.
- Experience utilizing combination of analytical, statistical, computational, and empirical methods to gain deep understanding of design and minimize overall development timelines.
Location: Bengaluru, India
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.