Senior Program Manager

Program Manager

Location: Malvern, PA (Onsite) MoI: Video and F2F

MUST HAVE — MUST LOOK FOR CLIENTS DOMAIN EXPERIENCE

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.

Client 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.

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 of new product features. Familiarity with both hardware and software applications and processes is required.
• Work with Operations, Field Service, Marketing, 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 to management on a regular basis.
• Deliver the programs as defined: on time, on budget, with high quality & compliance.
• Other duties as needed or required.

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.
• Experience with embedded and/or cloud based software platforms preferred.
• 3+ years as Program Manager in the medical device industry, with experience in leading at least one full program from concept to launch.
• 5+ years experience in a regulated industry (pharmaceutical, life sciences, aerospace, military, etc.)
• PMP certification preferred.

Physical Requirements:

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