On behalf of our client, a growing medical devices company, we are currently recruiting for a Program Manager.
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. As Program Manager, you will be responsible for managing cross-functional teams, ensuring alignment with business goals, and ensuring the successful delivery of innovative medical devices that enhance patient care. This role requires both technical expertise and a strong understanding of quality and regulatory standards within the medical device industry.
Reporting to: VP of Global Operations
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.
Required Skills & Qualifications:
- 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.
- Skills:
- Strong leadership abilities and experience managing cross-functional teams.
- Deep understanding of medical device development processes, including design control, validation, and regulatory compliance.
- Ability to communicate effectively with diverse stakeholders, from technical teams to senior executives.
- Expertise in program management tools (e.g., Microsoft Project, JIRA, or similar).
- Strong problem-solving, critical thinking, and decision-making skills.
- Experience with medical device product lifecycle management and quality management systems.
- Personal Traits: Detail-oriented, proactive, adaptable, with a focus on continuous improvement and patient outcomes.
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 and knowledge:
· 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.
To apply for this role please send CV to [email protected] or call Linda at 01 2784703. Thornshaw Scientific is a division of the CPL Group of companies. www.thornshaw.com
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