What are the responsibilities and job description for the Manufacturing Engineer position at Vastek, Inc.?
We are seeking a detail-oriented and proactive Manufacturing Engineer to join our team. This role will focus on supporting the design transfer, process development, validation, and continuous improvement of medical device manufacturing processes. The ideal candidate will have a solid engineering foundation, regulatory experience, and a passion for quality-driven innovation.Key ResponsibilitiesDevelop and improve manufacturing processes for medical device components and assemblies.Lead equipment selection, installation, qualification (IQ/OQ/PQ), and maintenance planning.Author and execute process validation protocols (including DOE and statistical analysis).Support design transfer activities from R&D to production.Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable standards.Identify root causes of manufacturing issues and implement effective CAPAs.Collaborate with Quality, R&D, and Supply Chain teams to optimize processes.Maintain and create manufacturing documentation including work instructions, BOMs, and routers.Participate in audits and support regulatory submissions as needed.Qualifications Required:Bachelor’s degree in Mechanical, Biomedical, Manufacturing, or Industrial Engineering.2 years of experience in a manufacturing engineering role, preferably in a medical device or regulated environment.Strong knowledge of GMP, FDA regulations, ISO 13485, and validation principles.Proficient in CAD (SolidWorks preferred), Microsoft Office, and statistical software (Minitab or JMP).Strong communication and cross-functional collaboration skills.ThanksSuchi | Recruitment Headsuchi@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 : $30 - $40