{"schemaVersion":"jobsearcher.job.v1","id":"8504bcb07d80e0eeee3f8f7f","url":"https://jobsearcher.com/jobs/8504bcb07d80e0eeee3f8f7f","canonicalUrl":"https://jobsearcher.com/jobs/8504bcb07d80e0eeee3f8f7f","title":"Process Development Engineer","description":"Process Development Engineer – Contractor (12 Months)\nLocation: Northern Area, Puerto Rico\nJob Type: Contract (12 months) | Full-time\nSchedule: Monday to Friday\nIndustry: Medical Devices / Pharmaceutical Manufacturing / Regulated Industry\nPosition Summary\nWe are seeking an experienced Process Development Engineer to support the development, validation, optimization, and implementation of manufacturing processes within a highly regulated environment. The ideal candidate will have a strong background in Manufacturing Engineering, coupled with an academic degree in Electrical Engineering or Mechanical Engineering, and demonstrated experience supporting process validation, equipment qualification, automation, and new product introductions.\nThis individual will work closely with cross-functional teams to develop robust manufacturing solutions while ensuring compliance with applicable quality and regulatory requirements.\nKey Responsibilities\nSupport process validation activities including IQ, OQ, PQ, and Process Performance Qualification (PPQ).\nDevelop and execute validation protocols, reports, and Master Validation Plans.\nDesign and implement receiving and in-process inspection systems for new products and manufacturing processes.\nGenerate and maintain technical documentation, including:\nEquipment evaluations\nPreventive maintenance procedures\nCalibration procedures\nManufacturing instructions and work procedures\nLead and support manufacturing process development projects from concept through implementation.\nCollaborate with Quality, Operations, R&D, Manufacturing, and other cross-functional teams.\nApply statistical and engineering tools including:\nDesign of Experiments (DOE)\nProcess Failure Mode and Effects Analysis (PFMEA)\nRisk assessments\nRoot cause investigations\nCharacterize, optimize, troubleshoot, and improve manufacturing processes.\nSupport implementation and qualification of manufacturing equipment and automated systems.\nParticipate in new product introduction (NPI) and process scale-up activities.\nEnsure compliance with quality system requirements and documentation practices.\nRequired Qualifications\nEducation\nBachelor's Degree in Electrical Engineering or Mechanical Engineering (required).\nExperience\nMinimum 5 to 7 years of experience in Manufacturing Engineering or Quality Engineering.\nExperience working within FDA-regulated industries, including:\nMedical Devices\nPharmaceuticals\nBiotechnology\nDiagnostics\nTechnical Skills\nStrong knowledge of:\n21 CFR Part 820\nGood Manufacturing Practices (GMP)\nISO 13485\nExperience with automated manufacturing systems and equipment.\nHands-on experience with:\nEquipment Qualification\nProcess Validation\nTooling and Fixture Design\nTest Method Development\nAutomation and Control Systems\nFamiliarity with:\nPLCs\nServo systems\nPneumatics\nIndustrial sensors\nVision systems\nExperience working with manufacturing technologies such as:\nLaser Welding\nHeat Bonding\nInjection Molding\nAutomated Assembly Systems\nQuality & Compliance Knowledge\nProficiency in:\nFMEA\nCAPA\nRoot Cause Analysis\nRisk Management Methodologies\nStrong technical writing and documentation skills.\nPreferred Qualifications\nExperience supporting new product development and product transfers.\nProject management experience within manufacturing environments.\nExperience driving continuous improvement initiatives.\nStrong analytical, problem-solving, and communication skills.\nQuality Expectations\nThe Process Development Engineer is expected to demonstrate a strong commitment to patient safety, product quality, and regulatory compliance by adhering to all applicable quality system requirements, procedures, and documentation practices. The successful candidate will actively support and promote continuous improvement within the Quality Management System.\nApply Today\nIf you are a Manufacturing Engineer with a degree in Electrical Engineering or Mechanical Engineering and experience in regulated manufacturing environments, we encourage you to apply and become part of a team dedicated to innovation, quality, and operational excellence.\nJob Types: Full-time, Contract\nWork Location: In person","company":"Econs","rawCompany":"econs","city":"Dorado","state":"PR","isRemote":false,"isActive":false,"createdAt":"2026-08-07T10:40:04.246Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"}],"industries":[{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Process Development Engineer","description":"Process Development Engineer – Contractor (12 Months)\nLocation: Northern Area, Puerto Rico\nJob Type: Contract (12 months) | Full-time\nSchedule: Monday to Friday\nIndustry: Medical Devices / Pharmaceutical Manufacturing / Regulated Industry\nPosition Summary\nWe are seeking an experienced Process Development Engineer to support the development, validation, optimization, and implementation of manufacturing processes within a highly regulated environment. The ideal candidate will have a strong background in Manufacturing Engineering, coupled with an academic degree in Electrical Engineering or Mechanical Engineering, and demonstrated experience supporting process validation, equipment qualification, automation, and new product introductions.\nThis individual will work closely with cross-functional teams to develop robust manufacturing solutions while ensuring compliance with applicable quality and regulatory requirements.\nKey Responsibilities\nSupport process validation activities including IQ, OQ, PQ, and Process Performance Qualification (PPQ).\nDevelop and execute validation protocols, reports, and Master Validation Plans.\nDesign and implement receiving and in-process inspection systems for new products and manufacturing processes.\nGenerate and maintain technical documentation, including:\nEquipment evaluations\nPreventive maintenance procedures\nCalibration procedures\nManufacturing instructions and work procedures\nLead and support manufacturing process development projects from concept through implementation.\nCollaborate with Quality, Operations, R&D, Manufacturing, and other cross-functional teams.\nApply statistical and engineering tools including:\nDesign of Experiments (DOE)\nProcess Failure Mode and Effects Analysis (PFMEA)\nRisk assessments\nRoot cause investigations\nCharacterize, optimize, troubleshoot, and improve manufacturing processes.\nSupport implementation and qualification of manufacturing equipment and automated systems.\nParticipate in new product introduction (NPI) and process scale-up activities.\nEnsure compliance with quality system requirements and documentation practices.\nRequired Qualifications\nEducation\nBachelor's Degree in Electrical Engineering or Mechanical Engineering (required).\nExperience\nMinimum 5 to 7 years of experience in Manufacturing Engineering or Quality Engineering.\nExperience working within FDA-regulated industries, including:\nMedical Devices\nPharmaceuticals\nBiotechnology\nDiagnostics\nTechnical Skills\nStrong knowledge of:\n21 CFR Part 820\nGood Manufacturing Practices (GMP)\nISO 13485\nExperience with automated manufacturing systems and equipment.\nHands-on experience with:\nEquipment Qualification\nProcess Validation\nTooling and Fixture Design\nTest Method Development\nAutomation and Control Systems\nFamiliarity with:\nPLCs\nServo systems\nPneumatics\nIndustrial sensors\nVision systems\nExperience working with manufacturing technologies such as:\nLaser Welding\nHeat Bonding\nInjection Molding\nAutomated Assembly Systems\nQuality & Compliance Knowledge\nProficiency in:\nFMEA\nCAPA\nRoot Cause Analysis\nRisk Management Methodologies\nStrong technical writing and documentation skills.\nPreferred Qualifications\nExperience supporting new product development and product transfers.\nProject management experience within manufacturing environments.\nExperience driving continuous improvement initiatives.\nStrong analytical, problem-solving, and communication skills.\nQuality Expectations\nThe Process Development Engineer is expected to demonstrate a strong commitment to patient safety, product quality, and regulatory compliance by adhering to all applicable quality system requirements, procedures, and documentation practices. The successful candidate will actively support and promote continuous improvement within the Quality Management System.\nApply Today\nIf you are a Manufacturing Engineer with a degree in Electrical Engineering or Mechanical Engineering and experience in regulated manufacturing environments, we encourage you to apply and become part of a team dedicated to innovation, quality, and operational excellence.\nJob Types: Full-time, Contract\nWork Location: In person","datePosted":"2026-08-07T10:40:04.246Z","dateModified":"2026-08-07T10:40:04.246Z","hiringOrganization":{"@type":"Organization","name":"Econs","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Dorado","addressRegion":"PR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"8504bcb07d80e0eeee3f8f7f"},"url":"https://jobsearcher.com/jobs/8504bcb07d80e0eeee3f8f7f"}}