Systems Engineer (Medical device)

Hello Everyone,

Greetings of the day.

This is Vydehi from Intellectt Inc. We currently have an opening for a Systems Engineer with one of our medical device clients. If you or anyone you know is interested in this opportunity, please feel free to send your updated resume to vydehi@intellectt.com or reach out to me directly at +1 732 355 7412.

Role: Systems Engineer I

Location: Columbia, MD

Duration: 5 Months (Hybrid. Expected to report to office 3 days a week.)

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

Job Description

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)
• Self driven
  
  

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