Project Engineer
1 month ago
Job Title: Project Engineer III Contractor
Surgical RD&E - Sustaining
Duration: 12 Month Contractor (possibility of extension or conversion)
Location: Hybrid - 3 days onsite- 13000 Deerfield Parkway, Ste 300, Milton, GA 30004
Hours: Hybrid, 3 days onsite, 8 hrs/day; Core hours 9:00-3:00 (Flexible for the other 2)
Description:
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 Responsibilities
Analyze 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
Required Skills Qualifications
Bachelor’s Degree in an Engineering field (BS in Chemical, Mechanical, or Biomedical Engineering preferred) and 1-2 years in product design/development
Medical Device Experience
Lead Project Meetings
Communication with customers
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
Preferred Qualifications:
Bi-lingual in Spanish
Microsoft Project
Medical device knowledge- class 1 Disposable Medical Device Product Development Experience
Manufacturing disposable products knowledge
Proven ability to independently manage and execute objectives
Knowledge of nonwoven and other medical device materials
Knowledge of GLP
Job Description:
Summary: The main function of a project engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. A typical project engineer can make engineering drawings and read and interpret blueprints.
Job Responsibilities:
Study time, motion, methods, and speed involved in maintenance, production, and other operations to establish standard production rate and improve efficiency.
Interpret engineering drawings, schematic diagrams, or formulas and confer with management or engineering staff to determine quality and reliability standards.
Read worker logs, product processing sheets, and specification sheets, to verify that records adhere to quality assurance specifications.
Aid in planning work assignments in accordance with worker performance, machine capacity, production schedules, and anticipated delays.
Prepare charts, graphs, and diagrams to illustrate workflow, routing, floor layouts, material handling, and machine utilization.
Observe worker using equipment to verify that equipment is being operated and maintained according to quality assurance standards.
Observe workers operating equipment or performing tasks to determine time involved and fatigue rate using timing devices.
Evaluate data and write reports to validate or indicate deviations from existing standards.
Skills:
Creativity, verbal and written communication skills, analytical and problem solving ability.
Team player and detail oriented. Ability to make sketches, engineering drawings and common computations.
Ability to read and interpret blueprints, technical drawing, schematics and computer-generated reports.
Previous experience with computer applications and software related to engineering field, such as Computer Aided Design (CAD).
Education/Experience:
Bachelor's degree in engineering required. 5-7 years’ experience required.
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