Who we want:

• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
• Goal-oriented orchestrators. People who can effectively coordinate and focus the work of skilled employees toward an important goal, prioritizing to the right activities that lead to success.
• Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.
• Curious learners. Technical project leaders with an innate curiosity that drives them to understand all aspects of New Product Development.

What you will do:

• Lead a cross-functional project team from early concept design to delivery of fully commercialized medical device. Closely monitor project performance to be able to recommend schedule changes, cost adjustments or resource additions as needed to deliver on project commitments. Investigate and develop solutions to problems during the research and planning phases. 
• Partner with Marketing and R&D to develop project business cases, determine user needs, and execute customer use trials.  Provide timely and accurate information and status updates to leadership throughout project life cycle.
• Provide overall project direction as related to schedule, cost, performance, and resources.
• Responsible for team dynamics and making sure the team optimally organized
• Develop and direct project team members
• Develop, monitor, and control project plans including:
  • Scope
  • Schedule / GANTT chart / Burndowns / Task Lists
  • Business Case / Capital Equipment Request
  • Risk / Resources / Budget

What you need:

• Total Experience 7-12 years with 5-6 years in technical & project management & scrum roles
• Education experience in BE/B.Tech/ME/M. Tech in Computer Science/ Electronics
• Strong ability to plan, track and facilitate projects using applicable tools (Gantt, Burndowns, etc.)
• Excellent interpersonal communications & technical problem-solving skills
• Demonstrated ability to lead/facilitate cross-functional teams
• Demonstrated outstanding organizational and technical knowledge
• Excellent analytical skills

Good to Have:

• PMP certification
• Strong knowledge & understanding of:
  • US FDA quality regulations 21CFR part 820
  • ISO 13485 standards