Medical Device Program / Project Manager

Job Summary:

We are seeking an experienced Program / Project Manager to lead medical device New Product Development (NPD) and R&D initiatives from early development through regulatory approval, product launch, and commercialization. The ideal candidate will have experience managing complex development programs involving hardware and software and leading cross-functional teams.

Key Responsibilities:

• Lead end-to-end medical device development programs from concept through commercialization.

• Develop and manage project plans, schedules, milestones, budgets, and deliverables.

• Coordinate teams across Engineering, R&D, Quality, Regulatory Affairs, Manufacturing, and Software Development.

• Oversee hardware and software integration activities and manage dependencies across development teams.

• Coordinate design controls, design reviews, risk management, and regulatory compliance activities throughout the development lifecycle.

• Identify and mitigate project risks, resolve issues, and escalate concerns affecting delivery.

• Communicate program status, priorities, risks, and decisions to stakeholders and leadership.

• Drive execution to meet business objectives, quality requirements, and regulatory milestones.

Required Qualifications:

• Proven NPD or R&D project/program management experience within the medical device industry.

• Demonstrated success leading complex medical device development programs.

• Experience managing products through development, regulatory approval, launch, and commercialization.

• Strong understanding of medical device development processes, design controls, risk management, and regulatory requirements.

• Ability to lead cross-functional teams and manage project schedules, budgets, dependencies, and deliverables.

• Strong communication, stakeholder management, problem-solving, and organizational skills.

Preferred Qualification:

• Experience managing medical device programs involving integrated hardware and software.

Key Skills: Medical Device NPD/R&D Program Management, End-to-End Product Development, Design Controls, Risk Management, Hardware/Software Integration, Regulatory Approval, Product Launch and Commercialization, Cross-Functional Team Leadership, Project Scheduling and Budgeting, Stakeholder Management, and FDA/Medical Device Regulatory Compliance.

Recruiter Contact:

Rudra Prasad Kunnath
Email:

prasad.kunnath@intellectt.com

Benefits:
Employees hired into this position are eligible for benefits subject to applicable plan terms and eligibility requirements.

• Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for the full cost of insurance premiums.

• Retirement: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

• Paid Time Off: No PTO is provided beyond what is required by applicable state and local laws.

Equal Employment Opportunity:

Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.