R&D Project Manager

About

The R&D Project Manager is responsible for leading cross-functional project teams in the development and commercialization of Class II and Class III medical devices within a regulated CDMO environment. This role drives projects from concept through commercialization, ensuring alignment to scope, schedule, budget, and quality requirements.

Working closely with the project technical lead, this role serves as the primary liaison between internal teams, customers, and external partners. The Project Manager proactively identifies risks, resolves issues, and maintains clear, consistent communication with customers throughout the project lifecycle.

This position requires strong organizational, technical, and leadership capabilities to effectively align resources, ensure regulatory compliance, and meet or exceed customer expectations. The R&D Project Manager plays a critical role in driving customer satisfaction, operational excellence, and revenue growth.

Duties and Responsibilities

• Lead multiple medical device development projects simultaneously from ideation through design transfer and manufacturing launch.
• Manage and guide cross-functional project teams, ensuring alignment between engineering, quality, manufacturing, supply chain, and customer stakeholders.
• Develop, maintain, and execute comprehensive project plans, including scope, schedules, budgets, resource allocation, risk management, and mitigation strategies.
• Identify, assess, and proactively communicate project risks and implement corrective actions to maintain project performance.
• Serve as the primary customer interface for assigned projects, ensuring timely updates, expectation management, and issue resolution.
• Support business development activities by contributing to proposals, quotes, and project scoping discussions.
• Ensure compliance with applicable design control requirements, FDA regulations, ISO 13485 standards, and internal SOPs.
• Collaborate with external vendors and partners for materials, components, tooling, and specialized services as required.
• Monitor project performance metrics and drive continuous improvement initiatives.
• Prepare and present accurate and timely project status reports to internal leadership and external stakeholders.
• Promote effective communication and collaboration between customers, Business Development, and internal operational teams to ensure continuity of project objectives and profitability.

Education

• Bachelor's or Master's degree in Engineering required.
• PMP or equivalent project management certification preferred.

Experience, Skills, and Abilities

• Minimum 3+ years of experience in an engineering role required.
• Minimum 3+ years of project management or project engineering experience strongly preferred.
• Demonstrated experience in Class II and/or Class III medical device development, including design controls and regulatory compliance.
• Strong leadership skills with the ability to influence cross-functional teams in a matrixed environment.
• Excellent organizational, time management, and prioritization skills.
• Strong analytical and problem-solving capabilities with a proactive approach to risk mitigation.
• Exceptional verbal, written, and interpersonal communication skills.
• Proficiency with Microsoft Project or equivalent project management tools preferred.
• Ability to effectively manage customer relationships and internal/external stakeholder expectations in a fast-paced environment.

Physical Demands

The physical demands described here are representative of those required to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities.

This role requires the ability to sit, stand, and perform routine office tasks including computer use, telephone communication, filing, and documentation activities. Normal visual and auditory capabilities are required, along with the ability to communicate effectively in person, via telephone, and in writing.

This position primarily operates in an office and laboratory environment and may also require presence in manufacturing areas where conditions may vary.

This description is not intended to be an exhaustive list of responsibilities, duties, skills, or working conditions. Aptyx reserves the right to modify job duties and responsibilities as business needs require.

Measurement of Performance

• Achievement of project objectives related to scope, schedule, budget, and quality.
• Customer satisfaction with project execution and deliverables.
• Compliance with regulatory requirements and internal quality systems.
• Timely and accurate completion of project reporting to internal and external stakeholders.
• Effective collaboration across development, manufacturing, and supporting functions to meet departmental objectives.
• Strong communication and alignment between customers and Business Development to ensure project continuity, profitability, and customer satisfaction.