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Project Engineer
2 months ago
Kelly currently is hiring a Project Engineer III for one of our premiere candidates in Milton, GA.
Hours/shift: Hybrid, 3 days onsite | 8 hrs/day; Core hours 9:00-3:00 (Flexible for the other 2)
Pay: $57.59/hr
12-month assignment (possible extension and possibility of conversion).
The Project Engineer III position is a critical role within the Surgical RD&E team. This position requires technical leadership skills and cross-functional teamwork. He or she will be the lead engineer to support RD&E’s Sustaining efforts. In this role the engineer will own specific projects and will be required to review and update the current finished good and raw material specifications; work with manufacturing for implementation of new tooling and validations; complete all verification/validation testing; and all documentation associated with this project. This will require knowledge and understanding of project management, Engineering Change Orders (ECOs) reading drawings/schematics, problem-solving skills, specification writing, and communication skills (verbal and written). Additionally, working knowledge of materials science, molding and machining operations, as well as test lab equipment is required
This individual will be required to interact closely with Supply Chain, Manufacturing, Quality and other RD&E team members. They will also be responsible for discussions with customers on changes that are being implemented on products. The role will require managing multiple product SKUs according to project management principles and maintaining compliance to regulatory and quality systems.
- Primary ResponsibilitiesAnalyze current drawings and specifications and update them to accommodate project needs
- Interface with corporate scientific teams, existing manufacturing sites, existing and new internal and external stakeholders that affect the in-scope products
- Work with cross functional teams for strategic efficiencies
- Create ECOs and gain alignment with their approvals
- Understand the risks associated with different strategic moves and brainstorm methods to reduce risk
- Provide technical support for all in-scope products
- Maintain project schedules up to date
- Function within all quality systems and regulations for medical devices
- Basic QualificationsBachelor’s Degree in an Engineering field
- 1-2 years in product design/development
- Experience writing technical documentation, including protocols and reports.
- Experience creating/reviewing finished goods specifications
- Experience working in cross-functional teams as technical specialist
- Experience leading a major project with a critical deadline
- Ability to work independently
- Effective communication skills, both written and verbal, organizational skills, and attention to detail
- Ability to Lead Project Meetings
- Able to maintain and update specifications.
- Capable to effectively communicate with customers.
- Soft skills required: Negotiation skills, Customer communication.
- Ability to gain alignment with cross functional team.
- Understand documentation processes.
- Preferred Qualifications: Class 1 Disposable Medical Device Product Development Experience
- 2-4 years’ experience in the medical device industry
- Proven ability to independently manage and execute objectives
- Knowledge of nonwoven and other medical device materials
- Knowledge of GLP
- Bi-lingual in Spanish
- Microsoft Project
- Medical device experience / knowledge
- Manufacturing disposable products knowledge
- Education/Experience Requirement: BS Engineering (Preferred: BS in Chemical, Mechanical, or Biomedical Engineering)
- Other:Interaction level with Mgmt/Team members: Depending on the project, there may be presentations to the VPs of the business. There will be interaction with the directors of the different cross functional departments.