Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, or related field.
5+ years of experience in medical device manufacturing engineering.
Proficiency in CAD software (SolidWorks, AutoCAD, or similar).
Knowledge of statistical process control (SPC) and lean manufacturing principles.
Understanding of medical device validation processes (IQ, OQ, PQ).
Thorough knowledge of ISO 13485:2016 Medical Device Quality Management System.
Experience with metal-based components and assemblies.
Responsibilities
Lead manufacturing process development and validation activities including engineering protocols and reports.
Troubleshoot and optimize manufacturing processes for medical devices to ensure efficiency and quality.
Write, review, and maintain manufacturing procedures and SOPs in compliance with FDA and ISO standards.
Design and implement manufacturing fixtures, tooling, and equipment for production.
Conduct root cause analysis and implement corrective actions to enhance product quality and efficiency.
Collaborate with Quality Assurance, R&D, and Production teams for seamless product launches.
Benefits
Health Care Plan (Medical, Dental & Vision)
Retirement Plan with Company Match
Paid Time Off, Personal Days, AND Birthday Holiday!
Lifetime Membership Subsidy and Wellness Resources
Life Insurance (Basic, Voluntary & AD&D)
Family Leave (Maternity, Paternity)
Short-Term & Long-Term Disability
Taco Thursdays!!!
Full Job Description
We are seeking an experienced Manufacturing Engineer with a strong background in medical device production to join our dynamic manufacturing team. This role requires a versatile professional who can manage multiple complex projects while ensuring compliance with stringent medical device industry standards and regulations. The ideal candidate will have 5+ years of experience in medical device manufacturing, demonstrating improved: manufacturing methods, systems and processes to produce a high-quality product.
RESPONSIBILITIES:
Process Development Lead manufacturing process development and validation activities: engineering protocols, IQ, OQ, PQ reports, bill of materials, assembling instructions, manufacturing instructions and procedures.
Process Support & Optimization: Troubleshoot & Optimize manufacturing processes for medical devices ensuring efficient production while maintaining quality standards.
Technical Documentation: Write, review, and maintain manufacturing procedures, work instructions, Standard Operating Procedures (SOPs), and process specifications in compliance with FDA regulations and ISO 13485 standards.
Fixture & Tooling Design: Design, develop, and implement manufacturing fixtures, tooling, and equipment for production of medical devices, ensuring proper functionality and compliance with design controls.
Problem Solving & Continuous Improvement: Lead root cause analysis investigations, implement corrective and preventive actions (CAPA), and drive continuous improvement initiatives to enhance product quality, reduce waste, and improve manufacturing efficiency.
Cross-Functional Collaboration: Work closely with Quality Assurance, R&D, and Production teams to ensure seamless product launches.
Requirements
Required:
Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, or related technical field.
5+ years of experience in medical device manufacturing engineering
Proficiency in CAD software (SolidWorks, AutoCAD, or similar)
Knowledge of statistical process control (SPC) and lean manufacturing; understanding of medical device validation processes (Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)).
Thorough understanding of ISO 13485:2016 Medical Device Quality Management System.
Metal based components, assemblies, and processing
Salary range: $100,000 to 140,000 depending on skills and experience
Benefits
Health Care Plan (Medical, Dental & Vision)
Retirement Plan with Company Match
Paid Time Off, Personal Days, AND Birthday Holiday!
Lifetime Membership Subsidy and Wellness Resources
