[Remote] Manufacturing Engineer

Note: The job is a remote job and is open to candidates in USA. Sriven Systems Inc. is seeking a Manufacturing Engineer specializing in medical devices. The role involves developing and optimizing manufacturing processes, leading process validation activities, and collaborating with various teams to ensure product quality and efficiency.ResponsibilitiesDevelop, implement, and optimize manufacturing processes for medical device productsLead process validation activities including IQ, OQ, and PQ protocols and reportsSupport new product introductions (NPI) and transfer products from R&D to manufacturingCreate and maintain manufacturing documentation, work instructions, SOPs, and process flow diagramsPerform root cause analysis and implement corrective and preventive actions (CAPA)Collaborate with Quality, R&D, Regulatory Affairs, Supply Chain, and Production teamsDrive continuous improvement initiatives focused on quality, yield, throughput, and cost reductionSkillsBachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Industrial Engineering, or a related field3–8+ years of manufacturing engineering experience within the medical device industryStrong knowledge of FDA regulations, GMP, ISO 13485, and medical device quality systemsExperience with process validation (IQ/OQ/PQ), CAPA, NCR, and change controlKnowledge of Lean Manufacturing, Six Sigma, and continuous improvement methodologiesExperience with statistical analysis and process capability studiesProficiency in CAD software and manufacturing process documentationStrong problem-solving, communication, and project management skillsCompany OverviewSriven Systems is an information technology company providing application development and maintenance services. It was founded in 1999, and is headquartered in Southlake, Texas, USA, with a workforce of 201-500 employees. Its website is http://srivensys.com.Company H1B SponsorshipSriven Systems Inc. has a track record of offering H1B sponsorships, with 3 in 2026, 24 in 2025, 26 in 2024, 17 in 2023, 32 in 2022, 28 in 2021, 78 in 2020. Please note that this does not guarantee sponsorship for this specific role.