Systems Engineer I

Hello this is Komal from Intellectt we have an opening for a Systems Engineer I in Columbia, MD. Please find the job details and description below and if interested You can reach me at [email protected] or call me at +1(732)-813-9025.

Role: Systems Engineer I

Location: Columbia, MD - 21046

Duration: 5 Months

Job Description

Work Site/Location: Columbia, MD. Hybrid. Expected to report to the office 3 days a week.

Work Schedule: Typical workday hours. (9-5 with 1 hour lunch).

Must Have Skill

• CAD experience (SolidWorks creation of part files, drawings files)
• GD&T
• Experience with starting/ process change order in PLM system (Agile)
• Project management (meeting delivery expectation, forecasting roadblock
• Effective communication and time management skills
• Organizational skills
• Authoring of specifications (material and purchasing specs).
  
  

Nice To Have Skills

Experience in equipment qualification (IQ, OQ , PQ)

Qualifications

• 2-5 years of Solidworks experience required creating parts and drawing 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
• Bachelor's 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 ensure 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 include organizational, time management, action-oriented, and communication.