is currently recruiting for a (Direct Hire) (Manufacturing Engineer)
job located in Gaithersburg, MD.
The Manufacturing Engineer provides operational support related to manufacturing, testing, shipping, and technical maintenance of instrumentation and software, including building of Instruments. Works independently. This individual reports to the Director of Engineering and Manufacturing.
- Orders parts, assembles electrical and mechanical sub-systems, for building, testing, and shipping instruments.
- Participates in the installation, calibration, operational and performance qualification of the instrumentation systems
- Designs fixtures and jigs to assist in inspection, assembly, and test
- Writes test protocols and reports and preform IQ/OQ/PQ
- Works with product develop engineering to support new product transfer from development to manufacturing. Creates all manufacturing documentation to support the release of a new product.
- Acts a s system expert - software user interface, instrument features, instrument messaging, error codes, etc..
- Provides training, technical support, and application customization at customer and/or partner sites.
- Conducts all activities in compliance with Standard Operating Procedures and Manufacturing Batch Records outlined in Quality Management System.
- Drafts and reviews procedures and work instructions for manufacturing and operations processes.
- Provides operational support and monitors assembly process control. Evaluates and recommends process improvements utilizing LEAN principles.
- Provides technical support to facilitate quality investigations, root cause analysis and corrective action/preventive action (CAPA) implementation
- Initiates engineering change requests as functional change owner and oversees the execution and implementation of proposed changes.
- Supports internal and external audits and quality system certification
- Assisting with other design and/or development activities.
- Complies with all applicable policies regarding health, safety, and environmental policies.
- B.S. / M.S. in Mechanical, electrical, Instrumentation or Biomedical Engineering or other related discipline with at least 3-6 years of hands-on assembly and testing of instrumentation systems specific to medical devices and/or laboratory equipment; or 10+ years of relevant work experience.
- Mechanical design, SolidWorks
- Prior experience with software development / programming for customization of user interface is desirable.
- Demonstrated computer skills; experience using MS Office [Word, Excel, PowerPoint]
- Able to troubleshoot mechanical and electrical components
- Customer oriented. Resolves customer problems and issues through technical expertise and troubleshooting
- Familiarity with manufacturing processes and design control
- Prior experience with LEAN manufacturing principles and is highly desirable
- Working knowledge of QSR, GMP, and ISO requirements preferred
- Team-oriented individual with strong verbal, written and interpersonal skills
- Has a “do what it takes” attitude to meet customer deadlines
- Minimum travel – less than 10%
Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly® Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we're here every step of the way to find your dream engineering job.
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posting ID: 606204149Posted: 2021-03-03