Senior Manufacturing Operations Engineer (Irvine)

Overview

Our client, a US Fortune 250 company and a global medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an accomplished Senior Manufacturing Operations Engineer

Job Title : Senior Manufacturing Operations Engineer

Location : Irvine, CA 92618 (Hybrid)

Duration : 12 Months contract with possible extension

Pay Rate : $50$57 per hour (W2)

Relocation Expenses / Assistance : NO

NO Visa Sponsorship / No H1Bs / No C2Cs

Position Overview

The Mechanical LCM Engineer will support key projects and initiatives related to Advanced Patient Monitoring systems. This role is instrumental in driving manufacturing and operational strategies, supporting new product commercialization, line extensions, ongoing manufacturing activities, partnerships with third-party providers, and product and process improvements.

Key Responsibilities

• Identify and implement opportunities to optimize manufacturing processes using engineering methods (e.g., Six Sigma, Lean) and technical design skills to redesign or validate parts, equipment, tools, and fixtures.
• Apply technical principles, data analysis, and problem-solving skills to support production at contract manufacturers.
• Lead and support manufacturing initiatives such as material qualifications, supplier / part / label changes, product enhancements, equipment qualifications, and tolerance stack analyses.
• Support projects including supplier transfers, system enhancements, cost reductions, labor efficiency improvements, and quality / compliance initiatives.
• Manage change control processes for manufacturing updates, including CAD revisions, change requests, process changes, Device Master Record updates, specifications, and testing or service processes.
• Review and assess incoming Product Change Notifications (PCNs) and route relevant changes to appropriate product owners.
• Maintain and refine PCN tracking systems; improve triage criteria and process efficiency.
• Deploy and analyze process metrics to measure, refine, and optimize process control and continuous improvement.
• Develop and execute protocols for complex experiments and tests to qualify / validate manufacturing processes; analyze results and prepare recommendations and reports.
• Resolve complex manufacturing and compliance issues (e.g., CAPA, non-conformances, audit findings).
• Create training and documentation materials (e.g., work instructions) to ensure smooth knowledge transfer to production teams.
• Lead project planning activities and ensure deliverables meet expectations using project management tools (project plans, risk assessments, etc.).
• Perform additional duties as assigned.

Education & Experience

• Bachelors degree in Engineering or a Scientific field with 5 years of experience, or
• Masters degree with 4 years of experience, or
• Ph.D. with relevant industry or combined industry / education experience.

Required Skills

• Proficiency in MS Office Suite, including MS Project.
• Experience with PLM systems such as Windchill (Teamcenter preferred).
• Proficiency with Mechanical CAD tools (SolidWorks, CREO, ProE).
• Strong written and verbal communication skills with the ability to build effective relationships.
• Basic understanding of statistical techniques.
• Experience with lab or industrial equipment.
• Solid understanding of engineering principles, best practices, and manufacturing processes.
• Strong problem-solving, analytical, organizational, and critical-thinking skills.
• Ability to lead initiatives and influence change.
• Knowledge of environmental, health, safety, and quality guidelines relevant to medical device manufacturing.
• Strong attention to detail with the ability to manage multiple priorities in a fast-paced environment.
• Ability to collaborate with cross-functional teams and senior stakeholders.
• Adherence to all company rules and safety requirements.

Preferred Qualifications

• Familiarity with medical device regulations (ISO 13485, CFR 820).
• Lean Champion and / or Six Sigma certification.
• Ability to read electronic schematics and mechanical drawings.
• Experience troubleshooting and documenting device, sub-assembly, and component failures.

Recruiter Contact Info

Sajag Bhardwaj

sajag.bhardwaj@ameritconsulting.com

www.ameritconsulting.com

I'd love to talk to you if you think this position is right up your alley, and assure prompt communication, whichever direction. If you're looking for rewarding employment and a company that puts its employees first, we'd like to work with you.

Company Overview :

Amerit Consulting is an extremely fast-growing staffing and consulting firm. Amerit Consulting was founded in 2002 to provide consulting, temporary staffing, direct hire, and payrolling services to Fortune 500 companies nationally; as well as small to mid-sized organizations on a local & regional level. Currently, Amerit has over 2,000 employees in 47 states. We develop and implement solutions that help our clients operate more efficiently, deliver greater customer satisfaction, and see a positive impact on their bottom line. We create value by bringing together the right people to achieve results. Our clients and employees say they choose to work with Amerit because of how we work with them - with service that exceeds their expectations and a personal commitment to their success. Our deep expertise in human capital management has fueled our expansion into direct hire placements, temporary staffing, contract placements, and additional staffing and consulting services that propel our clients businesses forward.

Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Applicants, with criminal histories, are considered in a manner that is consistent with local, state and federal laws.