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Systems Engineer I

3 months ago

Columbia, United States Integrated Resources Full time

Job Title: Systems Engineer I_US
Work Site/Location: Columbia, MD. Hybrid. Expected to report to office 3 days a week.
Work Schedule: Typical workday hours. (9-5 with 1 hour lunch).
Must Have Skill :
1. CAD experience (SolidWorks creation of part files, drawings files)
2. GD&T
3. Experience with starting/ process change order in PLM system (Agile)
4. Project management (meeting delivery expectation, forecasting roadblock
5. Effective communication and time management skills
6. Organizational skills
7. Authoring of specifications (material and purchasing specs).
Nice to have Skills :
1.) Experience in equipment qualification (IQ, OQ , PQ)
2.) Self driven

Job Description:
Qualifications
• 2-5 years of Solidworks® experience required creating part and drawings files, must understand and implement GD&T methodology.
• the ability to work a wide range of personalities in a team setting required
• Technical writing skills required
• Oral and written presentation skills required

Experience with a variety of sensing and measurement technologies (thermocouples, photoelectric, vision, laser, etc.)
Familiarity with a variety of manufacturing processes (machining, injection molding, additive manufacturing, sheet metal, welding, etc.)
Experience in product verification via test equipment development and equipment validation (IQ/OQ/PQ) within an FDA regulated or other regulated industry (i.e. medical device/pharma, aerospace, etc.)
Experience interfacing with documentation control systems
Bachelors Degree in engineering plus 3-5 years (of engineering experience in design and analysis within the medical device or another design-intensive industry Responsibilities
• Participates as a team member on product packaging design teams and performs related design functions; including equipment design and trouble shooting, analysis, and technical writing
• Analyzes problems in design, process, and test development
• Recommend/implement solutions
• Prepares and presents oral and written project updates and technical discussions
Writes and approves protocols and reports
• Manages testing outlined in protocols and test methods
• Manages/develops validation studies on equipment and processes in on-site packaging lab.
• Maintains a professional working relationship with internal and external customers and support staff
• Initiates new or revised documentation and tracks through appropriate approval cycles and implementation through PLM systems
• Understands and follows company procedures and regulatory requirements
• Develops and implements procedures/policy

Overview: Provides mid-level engineering activities of an organization's information systems. Typical Functions: Plans, designs, develops, evaluates, tests, and integrates an organization's systems infrastructure, including the implementation and design of hardware and software. Captures, understands, translates, and documents customer requirements. Defines system and product requirements; and generates mechanical, electrical, and software performance and reliability specifications and requirements. Creates and maintains programmatic and technical documentation to insure efficient planning and execution. Manages and documents system configurations and oversees all transitions into production. Performs troubleshooting and remediation, ensures successful project implementation, and performs post project end user support. 3-5 years of experience. Soft skills to include organizational, time management, action-oriented, and communication.