CAD Designer

Title: CAD Designer I

Location: Columbia, MD (Expected to report to office 3 days a week)

Duration: 6 Months

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

Job Description:

• 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).
• 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 part and assembly/drawings files, must understand and implement GD&T methodology.
• Technical writing skills required.
• Experience in product verification via test equipment development and equipment validation (IQ/OQ/PQ) within an FDA regulated or other regulated industry preferred (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 troubleshooting, 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.
• 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.