Equipment Engineer I

OSYPKA MEDTEC INC•Longmont, CO

9d•$72,000 - $79,000•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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).

Responsibilities

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.
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.
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.
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.
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.
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.
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.