Accentuate Staffing is working with a medical device manufacturing organization that is seeking a Manufacturing Engineer to support production transfer, process improvement, equipment qualification, and ongoing manufacturing operations. This position will play an important role in maintaining reliable, efficient, and compliant manufacturing processes while partnering with engineering, operations, suppliers, and other project stakeholders.
The ideal candidate will bring hands-on manufacturing engineering experience in a regulated production environment, including process validation, root cause investigation, risk analysis, and equipment or tooling support. This individual should be comfortable managing multiple technical projects, developing manufacturing documentation, solving production issues, and driving improvements related to quality, cost, efficiency, and manufacturability.
Responsibilities:
- Lead manufacturing engineering activities supporting production line setup, process optimization, equipment implementation, and the transfer of new or updated products into manufacturing.
- Develop and execute equipment and process validation activities, including protocols, testing, data analysis, documentation, and final reports.
- Investigate manufacturing and quality issues through root cause analysis while supporting corrective actions, nonconformance resolution, process risk assessments, and continuous improvement initiatives.
- Support manufacturing equipment, tooling, fixtures, calibration activities, preventive maintenance programs, and troubleshooting efforts to maintain dependable production operations.
- Develop and maintain manufacturing documentation such as work instructions, bills of materials, routers, device manufacturing records, process specifications, and associated production documentation.
- Partner across engineering, manufacturing, quality, vendors, and project teams to improve manufacturing methods, reduce costs, support packaging and test-method development, and maintain compliance with applicable quality and regulatory requirements.
Qualifications:
- Bachelor’s degree in Biomedical, Mechanical, Industrial, Electrical, or a related engineering discipline, or an equivalent combination of education and relevant engineering experience; approximately 5+ years of applicable experience preferred.
- Hands-on experience with manufacturing process development, equipment/process validation, DOE, validation protocol execution, technical reporting, and development or maintenance of process FMEAs.
- Strong problem-solving and project-management capabilities, including the ability to prioritize competing activities, analyze manufacturing issues, and independently drive projects to completion.
- Experience working in a regulated manufacturing environment; ISO 9001, ISO 13485, medical device, pharmaceutical, or other highly controlled manufacturing experience is strongly preferred.
- Technical knowledge of manufacturing equipment and processes such as assembly, packaging, heat sealing, vacuum forming, RF welding, cutting/forming, inspection/testing, electro-mechanical equipment, tooling, or fixtures is preferred.
- Strong written and verbal communication skills with proficiency in common engineering and business software; experience with CAD, SolidWorks, Minitab, statistical tools, project-management applications, or Lean Six Sigma methodologies is a plus.
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Job Type: Full-time
Pay: $85,000.00 - $115,000.00 per year
Benefits:
- Dental insurance
- Health insurance
- Vision insurance
Work Location: In person
