We are seeking a highly skilled and motivated Manufacturing Engineer. As the Manufacturing engineer, you will be responsible for monitoring, maintaining and improving manufacturing systems and processes. In this highly visible role, you will collaborate with cross-functional teams to support the manufacturing and operations department.
Responsibilities
· Identify and resolve production issues, including equipment malfunctions and process variations.
· Support NCRs, CAPAs, and process deviations related to manufacturing processes, equipment, and materials
· Write and update SOPs, as needed. Train production personnel on procedures and equipment operation.
· Analyze existing manufacturing processes, identify areas for improvement, and implement process improvements to enhance efficiency, reduce waste, and improve product quality
· Support validations (IQ/OQ/PQ), as needed – writing protocols, training operators, writing reports; make recommendations and justification for sampling plans
· Support facilities and construction projects to maintain current scale and future scale-up
· Support projects to onboard new packaging and production automation, as needed
· Analyze workflows, equipment placement, and space requirements to improve manufacturing efficiency
· Supervise Manufacturing Engineering Technician for production equipment and facilities maintenance, and production technician training
Skills and Qualifications
· Strong understanding of cGMP regulations for medical devices
· Experience working within a Quality Management System in medical devices
· Cleanroom experience
· Strong analytical and problem-solving skills
· Experience automating production processes
· Familiarity with Lean Six Sigma continuous improvement tools and principles
· Experience with ERP systems, QAD or similar systems preferred
· Self-starter - takes initiative
· Relevant technological knowledge
· Ability to lead and work independently
· Strong communication and interpersonal skills
Education and Related Experience
· Bachelor’s degree in Manufacturing Engineering, Industrial Engineering, or related field, Master’s degree preferred
· Minimum 3-5 years’ experience in medical device manufacturing or similar field
· Experience with JMP or similar statistical software
Job Types: Full-time, Permanent
Pay: $75,000.00 - $90,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Experience:

• Medical Device or Pharmaceutical manufactguring: 1 year (Required)
• Cleanroom: 1 year (Required)

Ability to Commute:

• San Luis Obispo, CA 93401 (Required)

Work Location: In perso

Please refer the Job description for details