Qualifications and Requirements
- Experience: Minimum of 3 years of maintenance experience in a production environment (mechanical, electrical, pneumatic, and PLC systems). Must have at least 3 years of overall manufacturing experience, including a minimum of 2 years of direct medical device industry experience.
- Technical Troubleshooting: Demonstrated capability maintaining, repairing, and troubleshooting motors, pneumatic tools, ovens, machinery, and PLC-integrated equipment.
- Quality System Compliance: Practical understanding of medical device Quality System requirements, specifically 21 CFR Part 820 and ISO 13485.
- Documentation Skills: Proficiency in Good Documentation Practices (GDP) and technical writing for manufacturing instructions, traveler files, notebooks, and change plans.
- Technical Drawings & Tools: Ability to read drawings and schematics. Experience with AutoCAD, SolidWorks, or similar CAD software is preferred.
- Systems & Software: Hands-on experience with equipment calibration workflows, preventive maintenance tools, and precision measuring instruments. Experience with SAP or another ERP system is preferred.
- Impactful Work: Work directly on medical devices where your equipment upkeep and process support directly safeguard patient safety and product quality.
- Collaborative Environment: A multidisciplinary setting partnering directly with Manufacturing Engineering, Quality, Production, and external suppliers.
- Professional Development: Opportunities to expand skills in prototype process development, fixture design, and protocol validation.
salary: $44,000 - $69,000 per year
shift: Second
work hours: 3:30 PM - 1:30 AM
education: High School
Responsibilities
- Preventive Maintenance (25%): Maintain production equipment availability and product quality by completing scheduled preventive maintenance on machinery, motors, pneumatic tools, ovens, and related hardware in accordance with specifications.
- Diagnostics & Repair (20%): Diagnose equipment and process problems using systematic observation, technical drawings, precision measurement, and testing instruments; execute repairs, upgrades, and troubleshooting to restore reliable operation.
- Calibration & Inventory Management (15%): Maintain equipment calibration schedules and records while managing spare parts, supplies, purchase requisitions, and receipts required for manufacturing continuity.
- Process & Engineering Support (10%): Assist engineers with nonconforming and rework data review, time studies, investigations, engineering builds, and technical data analysis.
- Validation Testing (10%): Execute testing protocols (IQ/OQ/PQ), TMVs, and other validation activities, accurately documenting results in full compliance with Quality System requirements.
- Fixture & Prototype Development (10%): Develop, test, and evaluate prototype processes, gauges, processing fixtures, test fixtures, racks, and wiring solutions.
- Documentation Control (10%): Create or revise Manufacturing Instructions, Product Travelers/DHRs, Tool Files, MOPs, test methods, change plans, and Engineering Notebook records.
The essential functions of this role include:
Skills
Qualifications
Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
