Technical Lead, Manufacturing Line
Intepros
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Job summary
Intepros seeks a Technical Lead, Manufacturing Line to provide engineering leadership for safe, compliant, efficient, and reliable manufacturing operations in California, with onsite locations in Northridge or San Diego. You will lead process validation, equipment qualification, and manufacturing changes while supporting NPI, line readiness, tech transfer, and scale-up.
This role requires strong cross-functional collaboration and a track record in medical device manufacturing or other regulated
Qualifications
- Demonstrated leadership in manufacturing engineering and NPI, with strong process validation and equipment qualification experience.
- Knowledge of FDA QSR and ISO 13485 requirements for medical devices.
- Experience with lean/continuous improvement and OEE to drive manufacturing efficiency.
Responsibilities
- Lead process validations, equipment qualifications, and manufacturing changes.
- Support NPI, process development, line readiness, tech transfer, and scale-up.
- Develop and optimize manufacturing processes, layouts, and production methods.
- Collaborate with Operations, Quality, R&D, Regulatory, and Supply Chain.
- Ensure compliance with FDA QSR, ISO 13485 and internal procedures.
- Troubleshoot issues and lead root-cause and corrective actions.
- Identify and mitigate risks impacting safety, quality, delivery, and continuity.
- Provide leadership for capital equipment, automation, and facility upgrades.
- Analyze manufacturing metrics like yield, capacity, throughput, LBM, and OEE.
- Drive CI and manufacturing efficiency initiatives.
- Serve as escalation point for line, including launches and post-launch support.
- Mentor and guide manufacturing and process engineers.
Skills
Job description
NPI – Product Innovation | Onsite | Northridge, CA or San Diego, CA
We’re seeking a Technical Lead, Manufacturing Line to provide engineering leadership for safe, compliant, efficient, and reliable manufacturing operations.
This role will serve as the primary technical/engineering lead for process validation, equipment reliability, product quality, capacity expansion, continuous improvement, and New Product Introduction (NPI).
- Lead process validations, equipment qualifications, and manufacturing changes
- Support NPI, process development, line readiness, technology transfer, and scale-up
- Develop and optimize manufacturing processes, equipment, layouts, and production methods
- Partner with Operations, Quality, R&D, Regulatory, Supply Chain, and Manufacturing Engineering
- Ensure manufacturing processes comply with FDA QSR, ISO 13485, and internal procedures
- Troubleshoot equipment/process issues and lead root-cause and corrective actions
- Identify and mitigate technical risks affecting safety, quality, delivery, and production continuity
- Provide technical leadership for capital equipment, automation, and facility upgrades
- Analyze manufacturing metrics including yield, capacity, throughput, LBM, and OEE
- Drive continuous improvement and manufacturing efficiency initiatives
- Serve as the primary technical escalation point for the manufacturing line, including product launches and post-launch support
- Mentor and provide technical guidance to manufacturing and process engineers
- Strong Manufacturing Engineering / Technical Leadership background
- Proven NPI / New Product Introduction experience
- Experience with process validation and equipment qualification
- Strong knowledge of FDA QSR and ISO 13485
- Manufacturing process development and optimization
- Experience with automation, capital equipment, and manufacturing scale-up
- Knowledge of Lean/continuous improvement and OEE
- Strong root-cause analysis and problem-solving skills
- Experience in medical device or other regulated manufacturing strongly preferred
- Excellent cross-functional leadership and communication skills
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