Project Manager, Covington, GA
About the role
This position provides technical leadership in support of design improvements or changes necessary for sustained production of medical devices. The role plays a key part in leading teams through development and FDA compliance issues involved with medical devices, while developing an understanding of current medical device markets and customer requirements.
Responsibilities
- Lead development and execution of R&D projects and programs through all phases and stage gates for successful commercialization of Class 1, 2, and 3 medical devices.
- Direct responsibility for project scope, schedule, and budget to balance business deliverables within resource and time constraints.
- Coordinate communication across multiple functions and manufacturing facilities to review and prioritize projects.
- Ensure projects are launched on time and meet established goals and objectives that support the financial and competitive goals of the organization.
- Provide the communication link between project teams, senior management, and other stakeholders.
- Actively identify and manage project risk while ensuring adherence to established processes and methodologies.
- Ensure Design Control requirements are met for the project and maintain responsibility for the Design History File.
Requirements
- Detail-oriented with the ability to organize large amounts of work and data, including strong documentation practices.
- Strong interpersonal skills in verbal and written communications, customer focus, influencing, and team building.
- Strong listening and assessment skills, along with problem-solving abilities.
- Proficient in using a personal computer with intermediate keyboarding skills and expertise in Microsoft Word, Excel, PowerPoint, Project, and Access.
- Spanish language skills are a plus.
Qualifications
- BS Degree in Engineering, Sciences, or equivalent.
- 4+ years of proven experience in the medical device industry.
- Demonstrated success as a project manager, leading NPD/SE projects and launching innovative medical products.
- Experience 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 and project management software.
- Innovative, self-motivated, and results-driven.
- Excellent interpersonal skills and strong oral and written communication, including reports and business correspondence.
- Ability to travel up to 25%.
- Manufacturing experience is a plus.
Location
Covington, GA. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations. Remote or field-based positions will have different workplace arrangements.
Employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.