Project Manager, Covington, GA
On-siteConcord, North Carolina, United States
Job Summary
Lead development and execution of R&D projects for Class 1, 2, and 3 medical devices through all phases and stage gates. Manage project scope, schedule, and budget to balance business deliverables within resource and time constraints while coordinating communication across multiple functions and manufacturing facilities. Ensure projects meet established goals, support organizational financial targets, and adhere to FDA and ISO regulations. Act as the communication link between project teams and senior management, actively identifying and managing project risks. Maintain Design Control requirements and oversee the Design History File. Requires 4+ years in the medical device industry, PMP certification preferred, and up to 25% travel. Minimum of four days of in-office presence required in Covington, GA.
Required Qualifications
- BS Degree in Engineering, Sciences or equivalent
- 4+ years proven experience in medical device industry
- Demonstrated success as a project manager, leading NPD/SE projects, and launching innovative medical products
- Experienced in Risk Management and contingency planning
- Proven track record to lead projects involving resources in multiple locations
- knowledge of FDA and ISO medical device development regulations
- Detail oriented and ability to organize large amounts of work and data
- This includes the need for good documentation practices
- Strong interpersonal skills required in the areas of verbal and written communications, customer focus, influencing, and team building
- Strong listening and assessment skills
- Strong questioning & problem-solving skills
- Proficient in the use of a personal computer with intermediate level of keyboarding skills and proficiency in Microsoft Word, Microsoft Excel, Microsoft Power Point, Microsoft Project, Microsoft Access
- Ability to travel up to 25%
- minimum of 4 days of in-office presence per week
- employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19
Desired Qualifications
- Project Management Professional (PMP) Certification preferred
- Manufacturing experience is a plus
- Spanish is a plus
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