Research and Development Program Manager

Job Description: R&D Project Manager – Medical Devices

Job Title: R&D Project Manager

Department: Research & Development / Product Development

Industry: Medical Devices / Medical Technology (MedTech)

Reports To: Head of R&D / Director of Engineering

Experience: 8–12 years (including relevant project management experience)

Location: As per business requirements

1. Job Summary

The R&D Project Manager will lead and manage end-to-end medical device development projects, from concept and feasibility through design, verification, validation, regulatory submission support, and product launch. The role requires close collaboration with R&D engineering, quality assurance, regulatory affairs, manufacturing, supply chain, clinical, and marketing teams to deliver safe, effective, compliant, and commercially viable medical devices.

The ideal candidate will have strong project management capabilities, technical knowledge of medical device development, and a thorough understanding of design controls, risk management, and applicable regulatory requirements.

2. Key Responsibilities

A. Project Planning and Execution

• Develop project plans, timelines, budgets, resource allocation plans, and key milestones for medical device development projects.
• Lead cross-functional project teams to ensure timely delivery within approved scope, cost, quality, and performance requirements.
• Track project progress, identify critical-path activities, manage dependencies, and implement corrective actions when required.
• Maintain project documentation, status reports, dashboards, risk registers, and management review presentations.
• Manage project scope, change requests, and escalation of critical issues to senior management.

B. Medical Device Product Development

• Lead product development activities from concept generation and feasibility assessment to design transfer and commercialization.
• Coordinate design inputs, design outputs, design reviews, prototype development, and engineering changes.
• Ensure appropriate planning and execution of design verification and design validation activities.
• Coordinate testing activities, including performance, electrical safety, software, biocompatibility, usability, packaging, and sterilization testing, as applicable to the device.
• Support technology development, product improvements, value engineering, and lifecycle management.

C. Quality and Regulatory Compliance

• Ensure project execution aligns with applicable medical device quality management system requirements and design control procedures.
• Coordinate risk management activities in accordance with ISO 14971, including hazard identification, risk evaluation, risk control, and residual risk assessment.
• Ensure design and development documentation is maintained in accordance with applicable requirements, including design history documentation where applicable.
• Work with Quality and Regulatory Affairs teams to support regulatory submissions and approvals in relevant markets.
• Ensure compliance considerations are addressed throughout the product lifecycle, including change control and design transfer.

D. Cross-Functional Team Management

• Collaborate with R&D, mechanical, electrical, software, systems engineering, Quality Assurance, Regulatory Affairs, Manufacturing, Supply Chain, Clinical, and Marketing teams.
• Define project roles, responsibilities, deliverables, and resource requirements.
• Facilitate project meetings, design reviews, technical discussions, and milestone reviews.
• Resolve cross-functional conflicts and drive timely decisions on technical and project-related issues.
• Communicate project status, risks, budget performance, and resource constraints to stakeholders.

E. Risk, Cost, and Schedule Management

• Identify and manage technical, regulatory, operational, supply chain, cost, and schedule risks.
• Develop mitigation plans and contingency strategies for critical project risks.
• Monitor project expenditure, resource utilization, and budget variance.
• Evaluate the impact of design changes on project timelines, costs, compliance, and product performance.
• Ensure effective supplier and external laboratory coordination, where applicable.

F. Design Transfer and Product Launch

• Coordinate design transfer from R&D to manufacturing, ensuring that design outputs are suitable for production.
• Support manufacturing process development, pilot builds, process validation, and production readiness activities, as applicable.
• Ensure manufacturing documentation, specifications, testing requirements, and acceptance criteria are appropriately established.
• Coordinate launch readiness activities with Manufacturing, Quality, Regulatory, Supply Chain, and Commercial teams.
• Support post-launch improvements, product changes, and lifecycle management activities.

3. Required Qualifications

• Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Electronics, Instrumentation, Medical Technology, or a related engineering discipline.
• Project management certification such as PMP or PRINCE2 is preferred.
• 8–12 years of relevant experience in medical device R&D, product development, engineering, or technical project management.
• Demonstrated experience managing cross-functional product development projects from concept through commercialization.
• Experience with design controls, verification and validation, risk management, and design transfer.
• Strong knowledge of medical device quality and regulatory frameworks.

4. Technical and Regulatory Knowledge

Candidates should have working knowledge of the following, as applicable to the product and target markets:

• ISO 13485: Medical device quality management systems.
• ISO 14971: Risk management for medical devices.
• FDA 21 CFR Part 820 / Quality Management System Regulation (QMSR): US medical device quality system requirements.
• EU MDR 2017/745: European medical device regulatory requirements.
• IEC 60601 series: Medical electrical equipment safety and essential performance, where applicable.
• IEC 62304: Medical device software lifecycle processes, where applicable.
• IEC 62366-1: Usability engineering for medical devices.
• Design verification, design validation, configuration management, document control, and change control.

5. Required Skills and Competencies

• Strong project planning, execution, and monitoring skills.
• Excellent leadership and cross-functional stakeholder management.
• Sound technical problem-solving and decision-making abilities.
• Effective communication, presentation, and negotiation skills.
• Proficiency in project management tools such as Microsoft Project, Jira, or equivalent.
• Ability to manage multiple projects and competing priorities.
• Strong analytical skills and a structured, risk-based approach to problem-solving.
• Ability to work effectively in a regulated product development environment.

6. Key Performance Indicators (KPIs)

• On-time achievement of project milestones.
• Adherence to approved project budgets.
• Completion of design verification and validation activities according to plan.
• Timely closure of project risks, issues, and action items.
• Completeness and quality of design and development documentation.
• Successful design transfer and manufacturing readiness.
• Achievement of planned regulatory submission and product launch milestones.
• Effective resource utilization and stakeholder satisfaction.

7. Preferred Experience

• Experience with Class II or Class III medical devices, depending on the product portfolio.
• Experience in diagnostic equipment, patient monitoring systems, surgical devices, implantable devices, medical electronics, or software as a medical device (SaMD).
• Exposure to new product introduction (NPI), design transfer, and manufacturing scale-up.
• Experience working with global regulatory markets and external testing laboratories.
• Experience managing projects using Agile, Waterfall, or hybrid methodologies, depending on the development environment.

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”

If you are inclined, I would be happy to set up some time to chat more about your background and career interests to see if there could be a possible match. Please feel free to call me on 732-806-7467 or send me email on [email protected]

Regards

Niraj kumar