Program Manager
About the Role
We are seeking an experienced 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
* 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.
* Work closely with product development, engineering, quality assurance, regulatory affairs, and commercial teams to ensure successful program execution.
* Regularly communicate program progress, risks, and milestones to senior management and key stakeholders.
* Ensure that all programs comply with relevant regulatory requirements (e.g., FDA, CE, ISO), managing documentation, testing, and approvals needed for device market entry.
* Oversee the quality assurance processes, ensuring the product meets the highest industry standards, regulatory requirements, and customer expectations.
* Manage resources effectively across multiple projects, ensuring teams are properly staffed and projects are completed on time and within budget.
* Continuously assess and enhance internal processes and methodologies to improve the efficiency, quality, and speed of program delivery.
* Monitor and control program budgets, providing financial oversight and making sure timelines are adhered to.
Required Skills and Qualifications
* At least 3 years of experience in program management, specifically within the medical device industry or a closely related field (e.g., healthcare, biomedical engineering). Experience in hearing technology or similar industries is highly desirable.
* Degree in Biomedical Engineering, Mechanical Engineering, Life Sciences, or a similar related field.
* Certifications: PMP (Project Management Professional), PgMP (Program Management Professional), or similar certifications. Familiarity with ISO 13485, FDA regulations, and other relevant industry standards is a plus.
Benefits
This role offers a competitive salary, excellent opportunity to develop your experience and career in an exciting medical device start-up company, hybrid working, and a positive work environment.
What We Offer
As a Program Manager at our company, you will have the opportunity to work in a dynamic, fast-paced, and rapidly evolving medical device environment. You will be part of a cross-functional team, working closely with product development, engineering, quality assurance, regulatory affairs, and commercial teams to ensure successful program execution. Our company values continuous improvement and patient outcomes, and we are committed to providing a supportive and inclusive work environment.
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