Program Manager Taiwan

7 days ago

Limerick, Limerick, Ireland Pale Blue Dot Recruitment Full time
- Engineering (Continuous Improvement / Lean / Projects)

Program Manager – Medical Device Industry

An exciting opportunity exists for an experienced Program Manager to lead strategic initiatives within the medical device sector. In this role, you will manage cross-functional teams to deliver innovative healthcare solutions from concept through to regulatory approval and commercialization. The ideal candidate will bring technical expertise, leadership, and a solid understanding of the medical device lifecycle, quality, and regulatory requirements.

Responsibilities Include but are not Limited to:

1. Program Leadership: Manage multiple complex programs across the full medical device development lifecycle—from ideation through design, testing, and regulatory approval—aligned with strategic business objectives.
2. Cross-Functional Collaboration: Work closely with product development, engineering, quality assurance, regulatory affairs, and commercial teams to drive seamless program execution.
3. Stakeholder Engagement: Communicate progress, risks, and key milestones clearly to senior leadership and stakeholders. Set and manage expectations across all teams.
4. Regulatory Compliance: Ensure all projects comply with global regulatory standards (FDA, CE, ISO). Manage required documentation, testing, and approvals for successful market entry.
5. Quality Oversight: Champion quality assurance processes to ensure products meet the highest industry standards, regulatory expectations, and patient needs.
6. Resource & Budget Management: Allocate resources across multiple projects efficiently, monitor budgets, and ensure on-time delivery.
7. Process Optimization: Drive continuous improvement in internal workflows, tools, and project methodologies to enhance quality and speed of delivery.
8. Team Leadership: Mentor and lead cross-functional teams, fostering collaboration, accountability, and high performance.

Job Requirements

Degree in Biomedical Engineering, Mechanical Engineering, Life Sciences, or a related discipline.

Minimum 5 years of experience in program or project management within the medical device industry or a related healthcare/biomedical field.

Experience in hearing technology or auditory-related devices is highly desirable.

PMP, PgMP, or equivalent project/program management certification.

Familiarity with ISO 13485, FDA regulations, and other applicable standards is a strong advantage.

Core Skills:

1. Proven leadership skills with the ability to manage and align multidisciplinary teams.
2. Deep understanding of medical device development, design control, validation, and regulatory compliance.
3. Excellent verbal and written communication skills, able to bridge technical and non-technical stakeholders.
4. Proficiency with project management tools (e.g., Microsoft Project, JIRA, or equivalent).
5. Strong analytical and decision-making capabilities.
6. Experience managing full product lifecycles and working within quality management systems.

Preferred & Desirable Qualifications:

1. Experience with hearing aids, implants, or similar auditory medical technologies.
2. Knowledge of FDA 21 CFR Part 820, ISO 13485 standards.
3. Hands-on experience with regulatory submissions and product launch strategies.
4. Understanding of demand planning, forecasting, and supply chain alignment.
5. Lean/Six Sigma experience for driving continuous improvement initiatives.
6. Strong attention to detail and quality focus.
7. Demonstrated ability to mentor teams and resolve complex challenges.
8. Flexibility to operate in a dynamic, fast-paced environment.
9. Willingness to travel internationally as required.

This is a unique opportunity to make a direct impact on the development of life-changing medical technology, while contributing to a growing, mission-driven organization focused on improving patient outcomes.

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