A large, global medical device company in Irvine, CA is looking to identify an
R&D/QA Engineering Technologist.Essential Job Functions:- Assist in the creation, coordination, and processing of essential documentation through Product Lifecyle Management (PLM) systems.
- Assist in organizing and maintaining Design History Files (DHF) and technical files
- Drafting documentation necessary to complete each phase of a project
- Contributes to the completion of specific programs and projects.
- Communicate with key stakeholders regarding Change Orders and Functional Requirements.
- Works with a cross-functional project team (mechanical, electrical, systems, software, marketing, regulatory, quality)
- Provides input to the team and immediate supervisor in accordance with Company procedures to correct problems or deficiencies, recommendations, and implementation of changes where indicated and approved.
- Compare the technical requirements and derive proposals for actions for related products.
Skills:- Engineering Change Orders and Functional Requirements
- Design control in a regulated industry
- PDM- Product documentation management system (example: Ignite)
- Strong written and verbal communication, interpersonal, and relationship building skills
- GDP (Good Documentation Practices)
- Strong computer skills, including usage of MS Office Suite; and CAD if applicable
- Ability to read and understand procedures, drawings, schematics and design requirements
- Knowledge and understanding of ECR software systems
- Ability to draft technical documents
- Strict attention to detail
- Must be able to work independently
- Experiences in laws and regulations in medical device industry is preferable
- Familiarity with Design Controls for medical devices and generating Design History Files (DHFs)
- Proven success working with PDM systems for engineering groups
- Experience with technical writing including but not limited to product requirements documentation, and engineering change orders.
- Technical understanding in one or several technical areas is a plus.
- Ability to manage confidential information with discretion
- Ability to manage competing priorities in a fast-paced environment
- Good computer skills in usage of MS Office Suite
- Prior experience with Integrity, Microsoft Dev Ops, and Teamcenter are a plus
- Good problem-solving and critical thinking skills
- Strict attention to detail
- Ability to interact professionally with all organizational levels
Education & Experience:- Associate's Degree in technical field, with 4-7+ years of experience in technical documentation required.
- Bachelor's Degree preferred.
We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.