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)
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
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Information Technology
Industries
Staffing and Recruiting
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