Key Responsibilities:

• Technical Leadership: Take ownership of critical technical tasks and provide guidance throughout the new product development lifecycle.

• Stakeholder Engagement: Liaise with key opinion leaders to gain insights into disease states and user needs, translating these requirements into technical specifications.

• Creativity and Innovation: Foster a culture of creativity within the team, generating innovative product solutions to address unmet needs.

• Prototype Development: Lead the development of test models, prototype performance evaluations, and hands-on assembly, testing, and analysis.

• Risk Management: Identify and manage key technical risks, implementing appropriate mitigations throughout the product lifecycle.

• Documentation and Reporting: Write and review procedures, protocols, specifications, and reports, ensuring all documentation aligns with quality standards.

• Commercialization Strategies: Identify and recommend optimal solutions for product commercialization, including market evaluation and product training material development.

• Intellectual Property Support: Encourage idea generation and support the filing of patents and new ideas across engineering teams.

• Project Planning: Develop detailed project goals, plans, and budgets, identifying critical tasks and setting team priorities.

• Performance Management: Manage cross-functional teams to deliver on performance, time, and cost targets while reporting progress across the organization.

• External Collaboration: Leverage and liaise with external resources to achieve project goals, including attending meetings with key opinion leaders to gather feedback.

• Quality System Compliance: Manage projects in accordance with quality systems, taking ownership of the design history file and leading design reviews.

• Marketing Material Development: Create presentations, videos, and demos to showcase the client product portfolio.

• Additional Duties: Perform other duties as assigned or required.

• Education:

  • Bachelor's Degree: Typically in project management, business administration, engineering, life sciences, or a related field.
  • Master's Degree: Preferred for senior positions.

• Experience:

  • Project Management Experience: 3-5 years of experience managing projects, preferably in the medical device industry.

• Skills:

  • Communication: Excellent verbal and written communication skills.
  • Leadership: Strong leadership and motivational abilities.
  • Organizational Skills: Effective time and resource management capabilities.
  • Problem-Solving: Strong analytical and problem-solving skills.
  • Decision-Making: Effective decision-making skills under pressure.
  • Technical Skills: Proficiency in project management software/tools (e.g., MS Project, JIRA, Trello).

• Certifications: (Preferred)

  • Project Management Professional (PMP)
  • Certified ScrumMaster (CSM)
  • Certified Associate in Project Management (CAPM)
  • Lean Six Sigma Certification