Posted on: November 10, 2018
Transfer product/Processes from R&D to Manufacturing using project management, design for manufacturability and cost, process/design excellence, LEAN, ergonomics and knowledge transfer methodologies to ensure effective implementation of equipment, processes, and new technology
Development of process specifications which ensure user needs are met
Perform Equipment and process qualifications (CD/IQ/OQ/PQ)
Collaborate with cross functional team to meet project deliverables.
Accountability (including hands on and resourceful) on troubleshooting, problem solving, and escalation of program risk to management when design transfer and scale-up to manufacturing do not work as expected
Required Skills, Experience
A minimum of 2 years of experience in medical device manufacturing is required.
Experience with key technologies and processes related to the assembly and manufacture of heart valves, surgical instruments, stents, catheters, delivery systems, and/or interventional devices is preferred.
Experience with use of process and design excellence methodologies including Six Sigma.
Familiarity with Design for Manufacturability, and LEAN experience leading to manufacturing efficiency improvement.
Ability to develop process specifications, collaborate with outside design firms and work with Operations personnel.
Knowledge of cGMP, EHS guidelines, FDA guidelines, and Process Validation.
Capable of analyzing and solving complex problems through innovative thought and experience.
Strong verbal/written communication and interpersonal skills including conflict and relationship management.
TalentBurst is an award winning IT, Accounting & Finance staffing firm headquartered in Boston with offices in San Francisco, Miami, Milwaukee, Toronto, Bangalore, and Gurgaon. Our clients include the leading social media, technology, banks, utilities, pharmaceutical, and biotech companies.We work with 75 of the Fortune 500 companies. Our recruiting team is one of the most successful in the industry and has a strong reputation for treating our employees well and helping you find your next dream project.BenefitsAt TalentBurst, one of our founding principles has been to provide our employees with the best benefits available. Benefits we have available include:• Health, Dental, and Vision Plan• 401(k) Plan• Life Insurance• Immigration assistance• Credit Union Membership• Direct Deposit• Vacation pay (only for FTEs)
Keywords: TalentBurst, Irvine , Engineer I, Engineering , Irvine, California
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