Equipment Engineer I

Job DetailsLevel: ExperiencedJob Location: Legal Address - Longmont, CO 80504Position Type: Full TimeSalary Range: $72,000.00 - $79,000.00 SalaryJob Category: EngineeringOsypka Medtec, Inc. Job Description Equipment Engineer I Position Snapshot Job Title Equipment Engineer I Department Operations / Engineering Reports To Lead Manufacturing Engineer Location Colorado (Onsite) FLSA Status Exempt Employment Type Full-Time Schedule Monday–Friday, day shift; occasional after-hours support for facility/equipment emergencies Salary Range $72,000 – $79,000 annually (commensurate with experience) Travel NONE   Position Summary The Equipment Engineer I is a hands-on, floor-based engineering role responsible for the day-to-day reliability, calibration, and performance of production and facility equipment supporting Class III medical device manufacturing. Working alongside the Equipment Technician as a collaborative peer (and reporting to the Lead Manufacturing Engineer), this role owns engineering-level decisions and execution if equipment validation, support calibration program execution, preventive maintenance planning, equipment troubleshooting, and facility/utility support. The role is structured as a development seat: the successful candidate will progress toward subject-matter expertise on specific equipment platforms (leak detectors, lasers, gloveboxes, gas systems) and a broader scope of quality and operations responsibilities over time. This is not a desk engineering role. The successful candidate enjoys being on the manufacturing floor, working with their hands, partnering with technicians and operators, and applying structured problem-solving to keep equipment running and the facility operating reliably. Key Responsibilities Equipment validation • Support the execution of PQ, OQ, and PQ protocols for new and modified equipment under the direction of the Lead Manufacturing Engineer, in alignment with OMI's Validation Master Plan. • Conduct change impact assessments and identify requalification or revalidation triggers (relocations, repairs, software updates, calibration drift, modifications to critical parameters). • Contribute to validation protocols, reports, deviation responses, and traceability matrices in accordance with 21 CFR Part 820, ISO 13485, and applicable internal QMS procedures. • Partner with Quality, Manufacturing Engineering, and equipment owners to ensure validation deliverables are technically sound, audit-ready, and tied to current calibration, PM, and equipment history records. • Support investigations when the validated state of equipment is questioned, including contribution to root-cause analysis and CAPA effectiveness verification. Calibration & Metrology Program • Execute and maintain calibration schedules for Setra, Ophir, Omega, and other instrumented equipment, including 3-month Ophir calibration checks. • Coordinate sensor swap-outs, shipping of equipment to calibration vendors, and onsite calibration support. • Support the GAGEpack calibration management system; develop technical proficiency to serve as a future SME, including SOP updates. • Investigate out-of-tolerance (OOT) events, support root-cause analysis, and document corrective actions per QMS requirements. • Maintain calibration records and history logs (e.g., QS-09-04-FM2 implementation and ongoing use). • Coordinate with external calibration providers (e.g., Transcat) and manage related vendor relationships. Preventive Maintenance & Equipment Reliability • Develop, maintain, and execute quarterly preventive maintenance plans (Q2, Q3, etc.) for production and facility equipment. • Manage equipment inventory and the equipment heat map; identify reliability trends and improvement opportunities. • Schedule and coordinate OEM service visits for PM and calibration activities. • Maintain active service agreements and recommend renewals or changes based on equipment performance. • Order PM parts and consumables (batteries, air bottles, calibration consumables) and maintain appropriate stock levels. Equipment Troubleshooting & Subject-Matter Development • Troubleshoot production equipment including FOBA laser marker (EQ0213), gloveboxes (EQ0235-A/B), leak detectors (EQ0249-D), Nelipak sealers, entrance ionizers (EQ0171), and pressure gauges. • Support glovebox port replacement and verification activities. • Develop expertise on leak detection systems (Agilent, Pfeiffer) and serve as a growing point of contact for leak detector technical issues. • Build subject-matter knowledge on microbulk gas systems and related vendor relationships. • Support production generators, ionizers, and other supporting equipment as needed. • Partner with the Equipment Technician on hands-on troubleshooting, bringing engineering-level analysis and documentation to issue resolution. Environmental Monitoring & Data Integrity • Conduct monitoring verifications and pull data logs from Setra, Onset, and other monitoring systems as requested by QA and the PM Technician. • Investigate data outage events (e.g., Onset outage analysis) and support quality investigations. • Support air flow and particulate monitoring requirements across cleanroom equipment (EQ0171, EQ0024, EQ0009). • Initiate and support purchase requisitions for monitoring equipment (Intemp, Setra CEMS, etc.). • Support biomonitoring activities and related coordination. Facility Engineering & Support • Coordinate facility projects such as HVAC louver installations, fridge replacements, gowning bench anchoring, and cleanroom modifications (e.g., moth skirts). • Manage backup humidification and other environmental controls. • Support Unit E gas storage operations and related safety practices. Cross-Functional Quality & Operations Support • Provide engineering support to the Equipment Technician on PMs, calibrations, training, and troubleshooting as a collaborative peer. • Support the Quality team on equipment-related investigations, NCMRs, CAPAs, and audit readiness. • Assist with waste chemical handling and spill response per established procedures. • Coordinate with OEMs and suppliers for technical support, service, and parts. • Perform other duties as assigned in support of operations and quality objectives. Required Qualifications • Bachelor's degree in Mechanical Engineering, Electrical Engineering, Industrial Engineering, Mechatronics, or a closely related engineering discipline. • 0–3 years of professional engineering experience (relevant internships, co-ops, or senior design projects considered for new graduates). • Demonstrated hands-on aptitude — comfort working with tools, equipment, and the manufacturing floor. • Strong analytical and structured problem-solving skills (root-cause analysis, 5-Why, basic statistical reasoning). • Effective written and verbal communication; able to document investigations, procedures, and recommendations clearly. • Ability to manage multiple concurrent priorities with appropriate attention to detail. • Willingness to work in a cleanroom environment with required gowning. • Authorization to work in the United States without sponsorship. Preferred Qualifications • Experience in a regulated manufacturing environment (medical device, aerospace, pharmaceutical, or similar). • Familiarity with FDA 21 CFR Part 820 and/or ISO 13485 quality system requirements. • Exposure to calibration management software (e.g., GAGEpack) or metrology programs. • Hands-on experience with cleanroom equipment, leak detectors, lasers, gloveboxes, or compressed gas systems. • Familiarity with environmental monitoring systems and data integrity expectations. • Experience supporting OOT, NCMR, or CAPA investigations. • Working knowledge of facility systems (HVAC, gas distribution, refrigeration). Key Competencies • Hands-on Orientation — energized by floor-based work and direct equipment engagement. • Root-Cause Mindset — pursues why, not just what. • Ownership — sees a task through to verified resolution and documentation. • Collaborative — partners effectively with technicians, operators, and quality personnel. • Learning Agility — quickly develops expertise on new equipment and systems. • Safety-First — operates with consistent awareness of personal, equipment, and product safety. Physical Demands & Work Environment • Frequent standing, walking, bending, kneeling, and reaching on the manufacturing floor. • Ability to lift, push, or pull up to 50 lbs (e.g., gas cylinders, equipment components) with or without reasonable accommodation. • Comfortable working on ladders or in lift equipment for facility maintenance tasks. • Cleanroom gowning required for portions of the workday. • Exposure to compressed gases, cleaning chemicals, and standard manufacturing hazards; appropriate PPE provided and required. • Occasional after-hours availability for facility or equipment emergencies (no formal on-call rotation).QualificationsOsypka Medtec, Inc.Equpiment Engineer I  Job Title Equipment Engineer I Department Operations/Engineering Reports To  Lead Manufacturing Engineer Location Colorado (Onsite)  FLSA Status Exempt Employment Type Full-Time Schedule Monday-Friday, day shift; occasional after-hours support for facility/equipment emergencies Salary Range $72,000 - $79,000 annually (commensurate with experience)  Travel NONE Position Summary The Equipment Engineer I is a hands-on, floor-based engineering role responsible for the day-to-day reliability, calibration, and performance of production and facility equipment supporting Class III medical device manufacturing. Working alongside the Equipment Technician as a collaborative peer (and reporting to the Lead Manufacturing Engineer), this role owns engineering-level decisions and execution if equipment validation, support calibration program execution, preventive maintenance planning, equipment troubleshooting, and facility/utility support. The role is structured as a development seat: the successful candidate will progress toward subject-matter expertise on specific equipment platforms (leak detectors, lasers, gloveboxes, gas systems) and a broader scope of quality and operations responsibilities over time. This is not a desk engineering role. The successful candidate enjoys being on the manufacturing floor, working with their hands, partnering with technicians and operators, and applying structured problem-solving to keep equipment running and the facility operating reliably. Key Responsibilities Equipment validation • Support the execution of PQ, OQ, and PQ protocols for new and modified equipment under the direction of the Lead Manufacturing Engineer, in alignment with OMI's Validation Master Plan. • Conduct change impact assessments and identify requalification or revalidation triggers (relocations, repairs, software updates, calibration drift, modifications to critical parameters). • Contribute to validation protocols, reports, deviation responses, and traceability matrices in accordance with 21 CFR Part 820, ISO 13485, and applicable internal QMS procedures. • Partner with Quality, Manufacturing Engineering, and equipment owners to ensure validation deliverables are technically sound, audit-ready, and tied to current calibration, PM, and equipment history records. • Support investigations when the validated state of equipment is questioned, including contribution to root-cause analysis and CAPA effectiveness verification. Calibration & Metrology Program • Execute and maintain calibration schedules for Setra, Ophir, Omega, and other instrumented equipment, including 3-month Ophir calibration checks. • Coordinate sensor swap-outs, shipping of equipment to calibration vendors, and onsite calibration support. • Support the GAGEpack calibration management system; develop technical proficiency to serve as a future SME, including SOP updates. • Investigate out-of-tolerance (OOT) events, support root-cause analysis, and document corrective actions per QMS requirements. • Maintain calibration records and history logs (e.g., QS-09-04-FM2 implementation and ongoing use). • Coordinate with external calibration providers (e.g., Transcat) and manage related vendor relationships. Preventive Maintenance & Equipment Reliability • Develop, maintain, and execute quarterly preventive maintenance plans (Q2, Q3, etc.) for production and facility equipment. • Manage equipment inventory and the equipment heat map; identify reliability trends and improvement opportunities. • Schedule and coordinate OEM service visits for PM and calibration activities. • Maintain active service agreements and recommend renewals or changes based on equipment performance. • Order PM parts and consumables (batteries, air bottles, calibration consumables) and maintain appropriate stock levels. Equipment Troubleshooting & Subject-Matter Development • Troubleshoot production equipment including FOBA laser marker (EQ0213), gloveboxes (EQ0235-A/B), leak detectors (EQ0249-D), Nelipak sealers, entrance ionizers (EQ0171), and pressure gauges. • Support glovebox port replacement and verification activities. • Develop expertise on leak detection systems (Agilent, Pfeiffer) and serve as a growing point of contact for leak detector technical issues. • Build subject-matter knowledge on microbulk gas systems and related vendor relationships. • Support production generators, ionizers, and other supporting equipment as needed. • Partner with the Equipment Technician on hands-on troubleshooting, bringing engineering-level analysis and documentation to issue resolution. Environmental Monitoring & Data Integrity • Conduct monitoring verifications and pull data logs from Setra, Onset, and other monitoring systems as requested by QA and the PM Technician. • Investigate data outage events (e.g., Onset outage analysis) and support quality investigations. • Support air flow and particulate monitoring requirements across cleanroom equipment (EQ0171, EQ0024, EQ0009). • Initiate and support purchase requisitions for monitoring equipment (Intemp, Setra CEMS, etc.). • Support biomonitoring activities and related coordination. Facility Engineering & Support • Coordinate facility projects such as HVAC louver installations, fridge replacements, gowning bench anchoring, and cleanroom modifications (e.g., moth skirts). • Manage backup humidification and other environmental controls. • Support Unit E gas storage operations and related safety practices. Cross-Functional Quality & Operations Support • Provide engineering support to the Equipment Technician on PMs, calibrations, training, and troubleshooting as a collaborative peer. • Support the Quality team on equipment-related investigations, NCMRs, CAPAs, and audit readiness. • Assist with waste chemical handling and spill response per established procedures. • Coordinate with OEMs and suppliers for technical support, service, and parts. • Perform other duties as assigned in support of operations and quality objectives. Required Qualifications • Bachelor's degree in Mechanical Engineering, Electrical Engineering, Industrial Engineering, Mechatronics, or a closely related engineering discipline. • 0–3 years of professional engineering experience (relevant internships, co-ops, or senior design projects considered for new graduates). • Demonstrated hands-on aptitude — comfort working with tools, equipment, and the manufacturing floor. • Strong analytical and structured problem-solving skills (root-cause analysis, 5-Why, basic statistical reasoning). • Effective written and verbal communication; able to document investigations, procedures, and recommendations clearly. • Ability to manage multiple concurrent priorities with appropriate attention to detail. • Willingness to work in a cleanroom environment with required gowning. • Authorization to work in the United States without sponsorship. Preferred Qualifications • Experience in a regulated manufacturing environment (medical device, aerospace, pharmaceutical, or similar). • Familiarity with FDA 21 CFR Part 820 and/or ISO 13485 quality system requirements. • Exposure to calibration management software (e.g., GAGEpack) or metrology programs. • Hands-on experience with cleanroom equipment, leak detectors, lasers, gloveboxes, or compressed gas systems. • Familiarity with environmental monitoring systems and data integrity expectations. • Experience supporting OOT, NCMR, or CAPA investigations. • Working knowledge of facility systems (HVAC, gas distribution, refrigeration). Key Competencies • Hands-on Orientation — energized by floor-based work and direct equipment engagement. • Root-Cause Mindset — pursues why, not just what. • Ownership — sees a task through to verified resolution and documentation. • Collaborative — partners effectively with technicians, operators, and quality personnel. • Learning Agility — quickly develops expertise on new equipment and systems. • Safety-First — operates with consistent awareness of personal, equipment, and product safety. Physical Demands & Work Environment • Frequent standing, walking, bending, kneeling, and reaching on the manufacturing floor. • Ability to lift, push, or pull up to 50 lbs (e.g., gas cylinders, equipment components) with or without reasonable accommodation. • Comfortable working on ladders or in lift equipment for facility maintenance tasks. • Cleanroom gowning required for portions of the workday. • Exposure to compressed gases, cleaning chemicals, and standard manufacturing hazards; appropriate PPE provided and required. • Occasional after-hours availability for facility or equipment emergencies (no formal on-call rotation).