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.
RequirementsDUTIES AND 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.
• Other duties and projects assigned.
QUALIFICATIONS:
• Education: Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, or related technical field.
• Experience: Minimum 5+ years of experience in medical device manufacturing engineering; proven experience with medical devices (metal based components, assemblies, and processing preferred).
• Technical Skills: 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)).
• Regulatory Knowledge: Thorough understanding of ISO 13485:2016 Medical Device Quality Management System.
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!!!
