Job Title: Program Manager
We are seeking an experienced and motivated Program Manager to oversee and drive the success of strategic projects and initiatives within the medical device industry.
Key Responsibilities:
* Program Management: 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.
* Cross-functional Collaboration: Work closely with product development, engineering, quality assurance, regulatory affairs, and commercial teams to ensure successful program execution.
* Stakeholder Communication: 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.
* Regulatory Compliance: Ensure that all programs comply with relevant regulatory requirements (e.g., FDA, CE, ISO), managing documentation, testing, and approvals needed for device market entry.
* Quality Control: Oversee the quality assurance processes, ensuring the product meets the highest industry standards, regulatory requirements, and customer expectations.
* Resource Allocation: Manage resources effectively across multiple projects, ensuring teams are properly staffed and projects are completed on time and within budget.
* Process Improvement: Continuously assess and enhance internal processes and methodologies to improve the efficiency, quality, and speed of program delivery.
* Budget and Schedule Management: Monitor and control program budgets, providing financial oversight and making sure timelines are adhered to.
* Team Leadership: Lead and mentor cross-functional teams, promoting collaboration, accountability, and a high-performance culture.
Requirements:
* Experience: At least 5 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.
* Education: 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.
Preferred Qualifications:
* Experience with hearing aids, implants, or other auditory devices.
* Familiarity with the FDA's 21 CFR Part 820 or ISO 13485 standards.
* Experience in leading teams through the regulatory approval process and product launch activities.
Desirable Skills:
* Global perspective and mindset with the ability to work effectively in multi-disciplinary teams.
* Good knowledge of demand planning and forecasting.
* Continuous improvement mindset & experience including Six Sigma/Lean Manufacturing.
* Strong attention to detail and commitment to quality.
* Ability to train and mentor team members and guide them to resolutions.
* Strong analytical problem-solving skills and able to make efficient decisions.
* Proven track record for identifying and implementing improvements to processes and mitigate risk.
* Flexibility to work in a dynamic, fast-paced, and rapidly evolving medical device environment.
* Willingness to travel internationally as required.