Job Title: Sr. Manufacturing Engineer
Client: Medical Device Manufacturing Company
Duration: 12 Months with possibility of extension
Location: San Diego, CA or Northridge, CA
Shift: 1st Shift
Travel: Approximately 50%
Description:
Job Summary
The Senior Manufacturing Engineer serves as the technical process owner for manufacturing process validation, equipment readiness, capacity expansion, and continuous improvement. This role focuses on improving yield, throughput, reliability, quality, and manufacturing efficiency while supporting production goals and manufacturing scale-up.
Key Responsibilities
Manufacturing Process Engineering
- Design and optimize manufacturing processes, procedures, and production layouts for semi-automated equipment.
- Adapt equipment and machine designs to factory and production conditions.
- Incorporate inspection and testing requirements into production plans.
- Develop and maintain process specifications, work instructions, and engineering documentation.
- Provide engineering guidance on equipment, manufacturing techniques, and design requirements.
Equipment & Process Validation
- Develop and execute equipment and manufacturing process validations.
- Create and execute IQ, OQ, and PQ activities.
- Develop and validate test methods.
- Inspect equipment, machinery, and tools to verify performance and efficiency.
- Investigate equipment/process deficiencies and implement corrective actions.
Automation & Advanced Manufacturing
- Support automation initiatives and advanced manufacturing technologies.
- Partner with equipment suppliers and internal teams to improve equipment capability and reliability.
- Support equipment readiness and manufacturing scale-up.
Quality & Problem Solving
- Act as the technical escalation point for complex manufacturing and quality issues.
- Lead root cause investigations using: 5 Why, Fishbone Analysis, Statistical Analysis
- Ensure manufacturing processes meet applicable quality and regulatory requirements.
Continuous Improvement
- Lead initiatives to: Improve yield and throughput, Reduce scrap, Optimize labor utilization, Improve manufacturing reliability, Eliminate production bottlenecks, Improve manufacturing processes and equipment, Develop manufacturing strategies for commercial production ramp-up
Regulatory Compliance
- Ensure manufacturing processes and procedures comply with: FDA Quality System Regulations (QSR), ISO 13485, Company quality procedures and requirements
Required Qualifications
- Bachelor's degree or equivalent qualifying foreign degree with 4+ years of relevant experience, OR
- Advanced degree with 2+ years of relevant experience.
- Advanced knowledge of manufacturing engineering principles.
- Practical knowledge of project management.
- Experience supporting medical device manufacturing operations.
Required Technical Skills
- Manufacturing process validation
- Equipment qualification
- IQ / OQ / PQ
- Test method validation
- Statistical analysis
- Process control methodologies
- Root cause analysis
- Continuous improvement
- Semi-automated manufacturing equipment
- Manufacturing process optimization
- Equipment reliability
- Manufacturing ramp-up and scale-up
- Cross-functional and equipment supplier collaboration
Ideal Candidate
The ideal candidate has strong medical device manufacturing engineering experience with hands-on knowledge of process validation, equipment qualification, continuous improvement, and structured problem solving. The candidate should be comfortable resolving complex technical issues, working with equipment suppliers, and supporting manufacturing scale-up.
Work & Travel
- 1st Shift
- Location: San Diego, CA or Northridge, CA
- Approximately 50% travel required
#ZR
As a leading contract, contract-to-hire and professional placement firm, Three Point Solution understands the importance of aligning our client with the right resource at the right time. We are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate. Our goal is to cultivate and maintain true partnerships with our clients and candidates.
