MedTech Project Leader: NPD & Regulatory Excellence

BD; Covington (GA); On-site; USD 105,000 - 145,000; Full time

Job summary

BD is seeking a technically adept Project Manager to lead R&D initiatives for medical devices, ensuring FDA/ISO compliance and successful product launches. The role requires coordinating multiple functions and sites, managing risk, and delivering projects on time and within budget.

The successful candidate will have a BS in Engineering or Sciences, 4+ years in medical devices, and PM experience; PMP preferred. On-site role in Covington, GA with up to 25% travel.

Qualifications

• BS Degree in Engineering, Sciences or equivalent.
• 4+ years proven experience in medical device industry.
• Proven track record leading NPD/SE projects, and launching innovative medical products.
• Experienced in Risk Management and contingency planning.
• Proven ability to lead projects involving resources in multiple locations
• Knowledge of FDA and ISO medical device development regulations
• Project Management Professional (PMP) Certification preferred
• Proficient with Microsoft Office Suite Project Management software
• Innovative, Self-motivated and Results driven
• Excellent Interpersonal skills
• Good oral and written communication, including reports and business correspondence
• Ability to travel up to 25%
• Manufacturing experience is a plus.

Responsibilities

• Lead R&D projects and programs through all phases for successful commercialization of Class 1, 2 & 3 medical devices.
• Direct responsibility for project scope, schedule & budget to balance business deliverables.
• Coordinate communication across functions and manufacturing facilities to review and prioritize projects.
• Ensure projects launch on time and meet established goals and objectives.
• Provide communication link between project teams and senior management and other stakeholders.
• Actively identify and manage project risk and ensure adherence to processes and methodologies.
• Ensure Design Control requirements are met and manage the Design History File.

Skills

Project management

Cross-functional collaboration

Communication

Problem solving

Documentation practices

Microsoft Office

Multi-location leadership

Spanish (plus)

Education

BS Degree in Engineering/Sciences or equivalent

4+ years medical device industry experience

PMI PMP Certification preferred

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Project

Microsoft Access

Job description

BD is seeking a technically adept Project Manager to lead R&D initiatives for medical devices, ensuring FDA/ISO compliance and successful product launches. The role requires coordinating multiple functions and sites, managing risk, and delivering projects on time and within budget.

The successful candidate will have a BS in Engineering or Sciences, 4+ years in medical devices, and PM experience; PMP preferred. On-site role in Covington, GA with up to 25% travel.