Program Manager

NeuroStar; Malvern; On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Program Manager to lead engineering and cross-functional teams in developing innovative medical products. This role is pivotal in guiding projects from concept through to launch, ensuring they meet quality standards and regulatory requirements. The ideal candidate will have a strong background in project management within the medical device sector, with proven skills in communication and problem-solving. Join a forward-thinking company dedicated to improving patient outcomes through cutting-edge technology and collaborative teamwork.

Qualifications

• 3+ years as Program Manager in medical device industry.
• Experience in leading full programs from concept to launch.

Responsibilities

• Lead cross-functional teams through product development process.
• Manage program budgets and project tracking metrics.
• Ensure compliance with FDA and quality regulations.

Skills

Project Management

Problem Solving

Communication Skills

Risk Management

Education

Bachelor of Science in Engineering

PMP Certification

Job description

Program Manager

Location

US-PA-Malvern

ID

2025-1260

Category

Product Development

Position Type

Regular Full-Time

Overview

Position Overview: The program manager is responsible for planning and leading engineering and cross-functional teams through the product development process for both new product introduction (NPI), installed base (IB) programs, and product life cycle programs. This is a highly visible role. The Program Manager will provide input into strategy and work with both management and individual contributors, to deliver innovative, market leading products - on time, on budget, with high quality & compliance.

Neuronetics is the industry leader in Transcranial Magnetic Stimulation (TMS) Therapy used in the treatment of drug resistant Major Depressive Order (MDD). TMS is cleared by the U.S. Food and Drug Administration (FDA) and uses a highly focused, pulsed magnetic field to stimulate function in brain regions known to affect mood. For more information, visit http://www.neurostar.com/

Responsibilities

Essential Duties/Responsibilities:

Lead a cross-functional core team through all stages of the Product Development Process (PDP): from concept development, detailed planning, design/implementation, verification/validation, manufacturing transfer, and product launch.
• Lead detailed program planning activities, establish robust project tracking metrics, run weekly project status meetings, and manage program budgets.
• Use risk management best practices to mitigate risks and ensure project success; lead efforts to identify root cause and resolve program, schedule and technical issues as they arise.
• Work with Product Development in the design, development, testing and release new product features.
• Work with Operations, Field Service, and Customer Support teams to ensure smooth transition of new products into manufacturing, providing ease of service in the field, and ensuring customer training is ready at launch.
• Work with Quality Assurance and Regulatory to ensure the teams and programs operate according to all released quality procedures and processes, and meet international regulatory requirements.
• Report program status management on a regular basis.
• Deliver the programs as defined: on time, on budget, with high quality & compliance.
• Other duties as needed or required.

Qualifications

Knowledge, Skill, and Abilities:

• Thorough understanding of the product development processes and cross-functional dependencies.
• General understanding of FDA Quality System Regulations (QSR 820.30), GMP, and ISO regulations 60601, 13485, and 14971.
• Strong oral and written communication skills.
• Possess excellent problem solving: six sigma trained and certified, or its equivalent.
• Demonstrated ability to build and lead teams, coordinate cross-functional activities, and resolve conflicts.

Education and Experience:

• Bachelor of Science Degree in Engineering or related technical field.
• Product technical design/development experience.
• 3+ years as Program Manager in the medical device industry, with experience in leading at least one full program from concept to launch.
• PMP certification preferred.

Physical Requirements:

• Must be able to remain in a stationary position 50% - 75%.
• Walking/Bending/Stooping 50% - 75% to access file cabinets, office equipment etc.
• Light to moderate lifting.
• Travel required up to 20% by air, rail, or auto within the United States.

*Applicants must be authorized to work for any employer in the US. We are unable to sponsor or assume responsibility for employment visa/work authorization at this time.

Neuronetics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Neuronetics makes hiring decisions based solely on qualifications, merit, business needs at the time.