Job Title: Program Manager
The company is seeking an experienced and motivated Program Manager to oversee and drive the success of strategic projects and initiatives within the medical device industry.
This role requires both technical expertise and a strong understanding of quality and regulatory standards within the medical device industry.
Key Responsibilities:
1. Lead and manage multiple programs that span the lifecycle of medical device development, from ideation through design, development, and regulatory approval, ensuring alignment with the company's strategic goals.
2. Work closely with product development, engineering, quality assurance, regulatory affairs, and commercial teams to ensure successful program execution.
3. Regularly communicate program progress, risks, and milestones to senior management and key stakeholders. Ensure that expectations are properly set and managed across all involved parties.
4. Evaluate and ensure compliance with relevant regulatory requirements (e.g., FDA, CE, ISO).
5. Oversee the quality assurance processes, ensuring the product meets the highest industry standards, regulatory requirements, and customer expectations.
6. Effectively manage resources across multiple projects, ensuring teams are properly staffed and projects are completed on time and within budget.
7. Continuously assess and enhance internal processes and methodologies to improve the efficiency, quality, and speed of program delivery.
8. Monitor and control program budgets, providing financial oversight and making sure timelines are adhered to.
9. Lead and mentor cross-functional teams, promoting collaboration, accountability, and a high-performance culture.
Required Skills & Qualifications:
1. At least 5 years of experience in program management, specifically within the medical device industry or a closely related field.
2. Experience in hearing technology or similar industries is highly desirable.
3. Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Life Sciences, or a similar related field.
4. PMP (Project Management Professional), PgMP (Program Management Professional), or similar certifications.
5. Familiarity with ISO 13485, FDA regulations, and other relevant industry standards is a plus.
Personal Traits: Detail-oriented, proactive, adaptable, with a focus on continuous improvement and patient outcomes.