| Manufacturing Engineer | Glens Falls, NY | Long term | onsite at Glens Falls, New York, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=250887&uid= From: SAGAR TOMAR, IT TRAILBLAZERS LLC [email protected] Reply to: [email protected] Position : Manufacturing Engineer Location: Glens Falls, NY Duration: Long term Keywords: Process Validation, PFMEA, Control Plans, Gage R&R, Manufacturing Process Development, IQ/OQ/PQ Job Description: Hands on experience in manufacturing process development, owning and driving projects to completion, with a proven work ethic and consistently exceeding results. Proficiency in equipment/ tooling/ material procurement and process design and development (molding/ assembly and associated process development). Ability to independently execute process validations, DOEs, and process characterizations for medical device process development. Knowledgeable in developing manufacturing specifications and related documentation such as SOPs, work instructions, etc. Knowledgeable with problem-solving skills, able to find innovative ways to resolve issues. Experience in Lean Six Sigma, Kaizen, or other problem-solving methodologies is an advantage. Proficient in using statistical techniques such as control charts, process capability, sampling plans. Author technical writing of IQ, OQ and PQ documentation. Create and review process risk assessments such as PFMEA. Ability to train manufacturing team on SOPs, validation activities, test methods, etc. Follow-up with Work Stream Leads from Manufacturing Plants and cross functional teams to assimilate project information daily. Knowledgeable on 21CFR 820, EU MDR, ISO 13485, ISO 14971. Manages project(s) risks and issues proactively. Provides work direction as required. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/ or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Technical degree required Experience working in a highly regulated industry (e.g., medical device, pharmaceutical) including hands-on experience in a manufacturing environment. Experience working on master validation activities (IQ/OQ/PQ, TMV), process mapping (current state-future state) and implementing effective procedures. Knowledgeable of medical device quality systems, FDA, and applicable ISO standards. Experience with problem solving methodologies. EDUCATION and/or EXPERIENCE Minimum undergraduate degree (BS) in Science, Mechanical/Industrial/Biomedical engineering 3+ years of experience in a manufacturing environment LANGUAGE SKILLS Must be able to speak and write English fluently; must be able to communicate clearly and accurately. Must be able to understand legally and technically written standards, regulations, and procedures Thanks & Regards Sagar Tomar Technical Recruiter Office: (732)-227-1772/ Ext: 226( Call or Text) Cell: (848)-271-1272 ( Call or Text) Email: [email protected] 485 E Route 1 South, Suite #100 Woodbridge Corporate Plaza, Iselin, NJ 08830 USA | CANADA | INDIA | HUNGARY | AUSTRALIA www.ittblazers.com An E- Verified Company Certified Minority Business Enterprise (MBE) Keywords: rlang information technology http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=250887&uid= |
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| 08:14 PM 04-Jan-23 |