Our client is a leading innovator in the medical device industry, dedicated to improving patient outcomes through cutting-edge technology and exceptional product quality. They are seeking a highly skilled and motivated Program Manager to join a dynamic team.
Job Summary: The Program Manager will oversee the planning, execution, and delivery of complex projects within the medical device sector. This role requires a strong engineering background, excellent project management skills, and a deep understanding of regulatory requirements in the medical device industry. The Program Manager will be the main point of contact for the customer and will be responsible for acquiring new accounts and increasing business with existing clients.
Key Responsibilities:
- Lead cross-functional teams to deliver projects on time, within scope, and within budget.
- Develop and maintain detailed project plans, including timelines, milestones, and resource allocation.
- Ensure compliance with all relevant regulatory standards and guidelines (e.g., FDA, ISO 13485).
- Interface with customers to understand their needs and work with internal teams to develop solutions.
- Identify areas to increase market share with customers.
- Participate in the RFQ process.
- Coordinate with engineering, quality assurance, manufacturing, and other departments to ensure seamless project execution.
- Identify and mitigate project risks and issues, and implement corrective actions as needed.
- Communicate project status, progress, and challenges to stakeholders and senior management.
- Foster a collaborative and high-performance team environment.
- Drive continuous improvement initiatives to enhance project management processes and outcomes.
Qualifications:
- Bachelor’s degree in Engineering (Mechanical, Biomedical, Electrical, or related field).
- Minimum of 5 years of experience in program/project management within the medical device industry.
- Strong knowledge of medical device development processes and regulatory requirements.
- Proven track record of successfully managing complex projects from inception to completion.
- Excellent leadership, communication, and interpersonal skills.
- Proficiency in project management software and tools (e.g., MS Project, Asana, Jira).
- PMP or similar project management certification is a plus.
Preferred Skills:
- Advanced degree (Master’s or PhD) in Engineering or related field.
- Experience with Agile project management methodologies.
- Familiarity with risk management and quality assurance practices in the medical device industry.
