Program Manager

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:

• 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.

• Cross-Functional Collaboration: Work closely with product development, engineering, quality assurance, regulatory affairs, and commercial teams to drive seamless program execution.

• Stakeholder Engagement: Communicate progress, risks, and key milestones clearly to senior leadership and stakeholders. Set and manage expectations across all teams.

• Regulatory Compliance: Ensure all projects comply with global regulatory standards (FDA, CE, ISO). Manage required documentation, testing, and approvals for successful market entry.

• Quality Oversight: Champion quality assurance processes to ensure products meet the highest industry standards, regulatory expectations, and patient needs.

• Resource & Budget Management: Allocate resources across multiple projects efficiently, monitor budgets, and ensure on-time delivery.

• Process Optimization: Drive continuous improvement in internal workflows, tools, and project methodologies to enhance quality and speed of delivery.

• Team Leadership: Mentor and lead cross-functional teams, fostering collaboration, accountability, and high performance.

• 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:

• Proven leadership skills with the ability to manage and align multidisciplinary teams.

• Deep understanding of medical device development, design control, validation, and regulatory compliance.

• Excellent verbal and written communication skills, able to bridge technical and non-technical stakeholders.

• Proficiency with project management tools (e.g., Microsoft Project, JIRA, or equivalent).

• Strong analytical and decision-making capabilities.

• Experience managing full product lifecycles and working within quality management systems.

Preferred & Desirable Qualifications:

• Experience with hearing aids, implants, or similar auditory medical technologies.

• Knowledge of FDA 21 CFR Part 820, ISO 13485 standards.

• Hands-on experience with regulatory submissions and product launch strategies.

• Understanding of demand planning, forecasting, and supply chain alignment.

• Lean/Six Sigma experience for driving continuous improvement initiatives.

• Strong attention to detail and quality focus.

• Demonstrated ability to mentor teams and resolve complex challenges.

• Flexibility to operate in a dynamic, fast-paced environment.

• 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.

Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.

Pale Blue Dot® Recruitment - The Resource for the MedTech Workforce