{"id":1330061,"url":"https://alion.io/job/trisalus-life-sciences-sr-manufacturingprocess-engineer","title":"Sr. Manufacturing/Process Engineer","company":{"id":3783091,"name":"Trisalus Life Sciences","domain":"trisaluslifesci.com","url":"https://alion.io/company/world-3783091","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"ADP","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Westminster, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":115000,"max":125000,"currency":"USD","period":"year","gross":null,"usd_annual":125000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"Design of Experiments","optional":false},{"name":"ISO 13485","optional":false},{"name":"Mandiant capa","optional":false},{"name":"Statistical Process Control","optional":false}],"status":"live","first_seen_at":"2026-06-29T20:08:00Z","employer_posted_date":"2026-06-29","last_verified_at":"2026-11-05T09:56:51Z","board_verified":true,"closed_at":null,"days_open":128,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":128},"description":"Duties and Responsibilities:\nLead the development, validation, and continuous improvement of manufacturing and process technologies for medical device products in accordance with FDA Quality System Regulations (21 CFR Part 820) and ISO 13485. \nServe as a senior technical resource for manufacturing and process engineering activities across multiple product lines. \nLead complex, cross-functional projects from concept through commercialization, including new product introductions, line extensions, and transfers from R&D to manufacturing. \nDevelop, qualify, and validate new manufacturing processes and equipment, including authorship and execution of IQ/OQ/PQ protocols, test method validations (TMV), and process validation reports. \nCreate and maintain the process validation master plan. \nApply statistical methods including Design of Experiments (DOE), Statistical Process Control (SPC), Measurement System Analysis (MSA/Gage R&R), and process capability analysis to develop, characterize, troubleshoot, and control manufacturing processes. \nLead risk management activities for manufacturing processes, including authorship and review of PFMEAs. \nDrive Design for Manufacturability (DFM) input during product development and design transfer activities. \nIdentify, evaluate, and implement opportunities to reduce cycle time, scrap, and manufacturing cost; develop and execute plans to capitalize on these opportunities. \nApply Lean manufacturing principles and continuous improvement methodologies to optimize production workflows, layouts, and equipment utilization. \nLead the evaluation, specification, design, and qualification of tools, fixtures, custom equipment, and production systems to meet capability and capacity requirements. \nMonitor process output, yield, and scrap; analyze trends and drive corrective actions to improve performance. \nPerform and oversee cleanroom (Class 8) validations as required. \nManage activities with outside vendors and contract manufacturers providing components, assemblies, processes, testing, and other services. \nLead investigations of nonconformances and support CAPA activities, including root cause analysis and effectiveness checks. \nAuthor, review, and approve standard operating procedures, work instructions, engineering change orders, and related quality system documentation. \nTrain production operators and technicians on new processes and ensure adherence to process standards. \nEnsure that product development and manufacturing activities are performed in accordance with U.S. Quality System Regulations and ISO 13485. \nMay supervise and provide technical direction to engineers, technicians, and operators; mentor junior engineers and technicians. \nPresent project status, technical findings, and recommendations to cross-functional teams and management. \nMaintain effective communications with supervisor, peers, and stakeholders. \nProvide strategic direction for specific projects and contribute to departmental planning. \nSupport day-to-day manufacturing activities as needed. \nQualifications\nEducation & Certifications:\nMinimum of BS in Mechanical, Biomedical Engineering or directly related scientific discipline.\nWork Experience:\nMinimum of 10 years' experience in a medical device manufacturing environment is required. \nFDA regulated work experience required. \nDemonstrated experience leading process validations (IQ/OQ/PQ) and manufacturing process development require\nKnowledge, Skills & Abilities:\nAble to read, write and understand English.\nStrong working knowledge of FDA 21 CFR Part 820 and ISO 13485. \nProficiency in statistical methods including DOE, SPC, MSA, and process capability analysis. \n Working knowledge of design controls, risk management, and CAPA processes. \nFamiliarity with Lean manufacturing and continuous improvement methodologies. \nStrong project management and technical leadership skills.\nPhysical Requirements:\nAble to work in both office and industrial/cleanroom 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