What are the responsibilities and job description for the Manufacturing Engineer-Medical Device position at Vastek, Inc.?
Job Title: Manufacturing Engineer – Medical DevicesIndustry: Medical Devices / Healthcare Manufacturing Job DescriptionWe are seeking a Manufacturing Engineer to support and improve manufacturing processes for regulated medical device products. The ideal candidate will have hands-on experience in manufacturing engineering within a FDA/ISO-regulated environment and a strong focus on process validation, continuous improvement, and compliance. Key ResponsibilitiesDevelop, implement, and optimize manufacturing processes to ensure efficiency, quality, and complianceSupport process validation activities including IQ, OQ, and PQLead manufacturing support for new product introductions (NPI) and design transfer from R&D to productionCreate and maintain manufacturing documentation such as SOPs, work instructions, and validation protocolsPerform root cause analysis and implement corrective and preventive actions (CAPA)Collaborate cross-functionally with Quality, R&D, Supply Chain, and Production teamsDrive continuous improvement initiatives using Lean / Six Sigma toolsEnsure compliance with FDA 21 CFR Part 820, ISO 13485, and internal quality systems Required QualificationsBachelor’s degree in Mechanical, Manufacturing, Industrial, Biomedical Engineering, or related field2–5 years of experience as a Manufacturing Engineer (medical device industry preferred)Strong knowledge of FDA QSR (21 CFR 820) and ISO 13485Experience with process validation (IQ/OQ/PQ)Familiarity with manufacturing equipment, tooling, and fixturesProficiency in CAD tools (SolidWorks, AutoCAD, Creo)Strong problem-solving and documentation skills Preferred QualificationsExperience in a cleanroom manufacturing environmentLean / Six Sigma Green Belt or Black BeltExperience with DFM/DFA principlesExposure to ERP/PLM systemsKnowledge of statistical tools (SPC, DOE) ThanksSuchisuchi@vastekgroup.comCompany DescriptionVastek Inc is managed by a group of dedicated professionals having rich experience of over years in Healthcare, IT consulting and staffing. We are a certified minority owned, Small business company head quartered out of San Diego, with coverage all across United States, Canada, Mexico, Italy and India. We specialize in Engineering, Validation, Regulatory, IT and NON-IT related areas primarily focused on Pharmaceutical / Life Sciences and Medical device companies.
Salary : $32 - $40