Mechanical Engineer

Mechanical Engineer II

Location: Newark, DE

Onsite Flexibility: Onsite

Contract Details

• Position Type: Contract
• Contract Duration: 12 months
• Pay Rate: $75.00 $100.00 / Hour (USD)
• Shift / Schedule: 8:00 AM 5:00 PM, Monday Friday
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Job Summary

This role designs, implements, and maintains quality assurance protocols and methods for processing materials into partially finished or finished products. Responsible for planning, implementing, and managing compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standards requirements for worldwide distribution. Designs methods and procedures for inspecting, testing, and evaluating the precision and accuracy of production processes, production equipment, and finished products. Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary. May assure compliance to in-house and/or external specifications and standards (i.e., GLP, GMP, ISO, Six Sigma).

Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise. Performs hands-on troubleshooting of electro-mechanical medical devices to identify root causes to non-conformances that occur during the manufacturing processes.

A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is a fully qualified, career-oriented, journey-level position. Normally receives little instruction on day-to-day work, general instructions on new assignments.

Key Responsibilities

• Responsible for identifying, diagnosing, prioritizing, and correcting technical issues that may arise in standard manufacturing processes; works in conjunction with other departments where appropriate.
• Evaluate and develop process control data for trending analysis; analyzes defects, provides feedback, and implements process improvements.
• Participates in design reviews, working with R&D and manufacturing to resolve all issues, particularly those arising from the violation of design standards or changes from existing manufacturing procedures.
• Actively supports and adheres to the Quality Policy and Quality System procedures.
• Identify and lead complex projects that drive meaningful improvements positively impacting product quality and manufacturing efficiency and costs.
• Write & Execute and Coach Others on how to perform TMVs.
• Write & Execute and Coach Others on Complex Change Orders (procedure updates, validations, clarifications, etc.).
• Lead/Own Moderate to Complex Project Change Orders (validations, risk analysis updates, creation or major changes of SOPs/documents, etc.).
• Write & Execute and Coach Others on how to perform PQs.
• Lead/Own CAPAs and HRAs/HHEs.
• Model all quality values and coach others on BSH quality system requirements and standards to elevate the team's ability to produce high-quality products and implement best practices that emphasize defect prevention, reduction in variation and waste, and provide for continuous improvement; collaborate and communicate effectively with junior level employees, peers, and cross-functional teams across all levels of the organization.
• Collaborates with Operations, Engineering, and R&D; accountable for ensuring that the products produced meet applicable regulatory and quality standards and customer expectations.
• Accountable for the development, training delivery, and monitoring of procedures, investigation procedures, and test methods in compliance with QMS, Medical Device Quality System Regulation, and Medical Device Directive requirements.
• Acts with urgency to identify and lead the timely resolution of quality issues.
• Lead moderate to complex risk management, defect investigation, customer complaint investigation, and corrective action activities; leads quality projects and will provide cost, schedule, and resource needs for assigned projects; responsible for monitoring and providing regular communication and updates on success factors such as progress, schedule, budget, project risks, and resource needs gaps; ensure data, protocols, and reports meet project objectives.
• Reviews technical publications, articles, and abstracts to stay abreast of technical developments in the industry; collaborate with other engineers and promote learning, development, and knowledge transfer; mentors and coaches junior Engineering staff.
• Provides technical expertise for Non-Conformance Events risk assessments and planned deviations.
• Author technical protocols, technical reports, and complaint investigation reports.
• Responsible for processes such as QSI, MRB, NCE, CAPA, and SCAR process.
• Responsible for the review and approval process for ECOs product-related change orders, engineering studies, sustaining engineering products, specifications, drawings, manufacturing procedures, design process verification, and validation documentation.
• Responsible for compliance-required facility and supplier audits and Notified Body and FDA inspections.
• Executes analysis of large datasets; analyze associated lines of investigation and devise and recommend methods to resolve problems.
• May participate in external collaborations.
• May present results and progress for management and key external customer review.
• Identify and recommend improvements to the organization, processes, procedures, and the Quality Management System.

Required Skills

• Excellent computer skills including ability to use word processing, spreadsheet programs, and databases.
• Excellent ability to read, analyze, and interpret professional journals, technical procedures, and government regulations.
• Excellent technical writing skills with ability to write quality assurance reports and detailed procedures.
• Good knowledge of microbiology, molecular biology, biochemistry, chemistry, and/or related disciplines.
• Good understanding of nucleic acid amplification and detection technologies.
• Good understanding of Scientific Method and statistical analysis.
• Ability to plan and supervise execution of projects, keep to timelines, and prioritize resources.
• Ability to troubleshoot and solve technical issues across multiple assays and platforms.
• Ability to analyze data and come to valid scientific conclusions.
• Ability to document technical work and lead investigations and improvements in a GMP environment.
• Knowledge of manufacturing, investigation, and quality improvement methodologies such as GMP, GDP, CIMS, Lean, Root Cause and Root Cause Failure Analysis, TQM, SPC, and Six Sigma.
• Good technical writing skills and ability to prepare and present data.
• Excellent collaboration and interpersonal skills.
• Core focus is hands-on troubleshooting and investigation work.
• Candidates should have experience diagnosing issues within electromechanical systems/devices.
• Heavy cross-functional collaboration with manufacturing engineering and sustaining engineering.
• Ideal profile is hands-on, problem-solving engineer.
• Strong resumes will clearly show real-world troubleshooting examples and root cause analysis.

Preferred Skills

• Working knowledge of FDA and ISO regulations that govern the Medical Device is beneficial.
• Certified Quality Engineer is beneficial.
• Experience with cleanroom processes is beneficial.
• Experience troubleshooting mechanical or electrical medical devices is preferred.
• Medical device experience is helpful but not required broader electromechanical experience is acceptable.
• Any experience with NCE investigations and documentation is a plus.
• Exposure to working in a quality management system (such as Agile or similar) is a plus.

Education Requirements

• Preferred Minimum Technical/Advanced Degree: Technical Bachelor's Degree in Mechanical or Electrical Engineering.
• Must have a degree in Mechanical or Electrical Engineering (non-negotiable).
• 2 5 years with Technical Bachelor's Degree, 1 3 years with Master's Degree, 0 1 years with PhD.

Required Experience

• 2 5 years of experience with a Technical Bachelor's Degree; 1 3 years with a Master's Degree; 0 1 years with a PhD.

Nice-to-Have Experience

• Experience with cleanroom processes is beneficial.
• Experience troubleshooting mechanical or electrical medical devices is preferred.
• Medical device experience is helpful but not required broader electromechanical experience is acceptable.
• Any experience with NCE investigations and documentation is a plus.

Work Environment / Physical Requirements

• Sit; use hands to finger, handle, or feel objects, tools, or controls.
• Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
• Lifting/moving and carrying products weighing up to 40 pounds.
• Exposure to moving mechanical parts, vibration, and/or moderate noise levels.
• Exposure to hazardous chemicals or other materials.
• Safety shoes with impact and compression protection must be worn in designated areas.
• Exposure to high voltage electronics and radiation; ability to work in clean room, controlled environment, and/or dark room.
• 100% onsite role; no expected overtime.

Important Notes

• This is a contract role only no guaranteed conversion, though strong performers may be considered long term.
• Initial team interview conducted via Microsoft Teams; onsite interview may occur for local candidates only.
• Looking for mechanical or electrical engineers only; do not submit quality engineers or biomedical engineers this is a hands-on technical troubleshooting role.
• Avoid candidates who are purely quality/compliance or design-only with no troubleshooting depth.

About the Client

Industry: Medical Device Manufacturing. Typical roles include Receiving Inspector, Manufacturing Technician, and Quality Assurance. Work type is on-site. Comprehensive job descriptions with detailed responsibility breakdowns, clear contract terms, and explicit work authorization requirements. Consistent emphasis on quality standards, regulatory compliance, and technical documentation skills. FDA-regulated medical device environment; GMP (Good Manufacturing Practices) and GDP (Good Documentation Practices) compliance required; potential exposure to hazardous materials and bloodborne pathogens; strict work authorization requirements with no visa sponsorship available. Heavy focus on quality control and inspection processes; contract roles vary from 6 12 months; manufacturing roles based in Newark, DE facility; positions require experience with ERP systems (Oracle, Agile PLM) and quality control instrumentation; emphasis on women's health and diagnostic/treatment technology; benefits package consistent across roles (medical, vision, dental, 401k).

Benefits

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

About GTT

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.

Job Number: 26-07742 Industry: Engineering

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