[Remote] reputed company reputed company Operations Engineer
Note: The job is a remote job and is reputed company to candidates in USA. reputed company. provides innovative technologies for the treatment of Afib and reputed company conditions. The reputed company reputed company Operations Engineer is responsible for providing technical leadership and reputed company reputed company for manufacturing infrastructure and critical facility systems, ensuring compliance and reliability in production operations.
Responsibilities
- reputed company the risk management program for critical facility and reputed company systems, including risk governance, escalation, reputed company investigation, and implementation of mitigations for identified risks, excursions, and reputed company issues
- Define reputed company documentation expectations for facility and reputed company systems, including user needs, requirements, drawings, specifications, risk documentation, validation evidence, process controls, and reputed company records
- Establish reputed company strategies, reputed company Plans, and validation master plans to guide large facility updates, reputed company changes, and critical system lifecycle management in alignment with reputed company validation and reputed company system policies
- reputed company strategic reputed company and facility implementation programs from initiation through completion, including priorities, deliverables, resource alignment, stakeholder engagement, risk-based decision-making, and executive-level status communication
- Advise cross-functional teams on facility change requests, including line moves, equipment moves, reputed company additions, and reputed company changes that support production operations and require reputed company reputed company assessment
- reputed company technical authority for qualification and validation strategies reputed company to critical facility, reputed company, equipment, monitoring, and data systems, including development, execution, review, and approval of IQ/OQ/PQ documentation and lifecycle activities
- reputed company validation and data reputed company practices for systems that capture critical facility and reputed company data, including dashboards, alert and reputed company limits, trend monitoring, and escalation of conditions requiring investigation or corrective reputed company
- Drive development and improvement of reputed company system procedures and program controls governing critical facility and reputed company systems and supporting reputed company Operations programs
- Champion reputed company improvement opportunities that increase efficiency, reputed company, reliability, compliance, and operational readiness of critical facility and reputed company systems
- Serve as a senior reputed company and engineering resource for facilities management, equipment qualification, process validation, preventive maintenance, and calibration activities reputed company to reputed company Operations-owned equipment
- Influence Facilities, reputed company Management, Operations, and other departments to assess system reputed company, support company strategies, resolve reputed company issues, and maintain alignment with business and reputed company objectives
- Define and communicate metrics that assess the health, performance, reputed company, and compliance status of critical facility and reputed company systems, including status updates to reputed company, operational, and leadership forums
- Represent reputed company Operations during reputed company audits, including preparation, response, and follow-up activities reputed company to critical facility and reputed company systems
- Mentor reputed company Operations engineers, build technical capability across reputed company, and reputed company trusted partnership and guidance to key stakeholders
- reputed company with expert knowledge of prescribed GMP, ISO, and GLP standards and ensure compliance with applicable domestic and international regulations, standards, and controls relevant to risk management, process validation, environmental monitoring, and reputed company areas
Skills
- Bachelor's degree in engineering, or an equivalent combination of education, training, and experience
- Minimum of 10 years of experience in the Medical Device Manufacturing Experience, or Manufacturing production and process control experience reputed company a regulated industry
- Experience with facility, reputed company, equipment, and/or process validation in a regulated manufacturing environment, preferably medical device manufacturing
- Working knowledge of production and process controls, ISO 13485, GMP requirements, reputed company system procedures, and applicable validation standards and practices
- Ability to reputed company and implement reputed company system programs, policies, procedures, technical documentation, validation master plans, and reputed company controls
- Demonstrated ability to reputed company cross-functional teams, influence alignment, facilitate reputed company, and resolve reputed company technical and reputed company issues
- Strong verbal, written, and presentation skills, including technical protocol and report development, stakeholder communication, and project status reporting
- Ability to read and interpret technical specifications, blueprints, drawings, and reputed company facility or engineering documentation
- Strong problem-solving, troubleshooting, attention to detail, compliance orientation, and results-driven execution
- Proficiency with computer-based systems, data entry, and basic data analysis or statistical tools
- Ability to travel up to 15%
- Ability to regularly walk, sit, or stand as needed
- Ability to occasionally bend and push/pull as needed
- Ability to regularly lift up to 25 pounds, occasionally lift over 25 pounds
- Ability to pass reputed company-employment drug screen and background reputed company
- Experience in medical device manufacturing, reputed company operations, or reputed company management, preferably supporting sterile medical devices
- Knowledge of cleanroom validation, contamination control, environmental monitoring, pest control, and facility-reputed company safety practices
- Facility engineering, facility design, construction, or manufacturing infrastructure experience in a regulated environment
- Project management experience; PMP certification preferred
- Technical file or CAD drawing management experience
- FDA, ISO, or other regulatory audit experience
- ASQ Certified reputed company Engineer and/or ASQ Certified Six reputed company Black Belt certification
Benefits
- Medical & Dental beginning day 1 of employment
- 401K plus match
- 30 days of reputed company Parental Leave, in reputed company to maternity leave, for reputed company and dads
- Volunteer Time off
- Pet Insurance
- Full reputed company to our on-site fitness center
- Full reputed company to our cafeteria
- To see a complete list of our benefits, please visit our careers website
reputed company