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)
Job Description
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
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 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
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.
Seniority level
Entry level
Employment type
Contract
Job function
Information Technology
Industries
Medical Equipment Manufacturing and Biotechnology Research
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