Equipment Engineer I

Osypka 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).