Manufacturing Engineer

• Senior ATR International
• 3.8 Pasadena, CA Job Details Contract $70.00
• $85.

50 an hour 1 hour ago Benefits Health insurance Dental insurance Vision insurance Qualifications Statistics Quality control statistical data analysis Manufacturing facility experience Statistical analysis Production validation processes Medical device manufacturing facility experience Biomedical manufacturing processes Test validation method Factory experience

Full Job Description Job Title:

Senior Manufacturing Engineer

•

Medical Device Validation & Operations Location:

Northridge, CA 91325 or San Diego, CA (Travel up to 50%)

Position Type:

12-

Month Contract Pay Rate:

$70.00

• $85.

50 / hour (determined due to experience) About the Client Our client is an industry-leading medical device innovator dedicated to developing life-changing healthcare technology. With a global reputation for high-quality engineering, compliance, and cutting-edge automation, they offer a dynamic, fast-paced environment where top technical talent can make a direct impact on patient outcomes. Join an exceptional team driven by precision, operational excellence, and continuous improvement. Position Summary We are seeking three (3) Senior Manufacturing Engineers to act as technical process owners supporting the Baja Consumable Lines initiative . In this role, you will lead manufacturing process validations, equipment readiness, capacity expansion, and continuous improvement initiatives. You will work closely with cross-functional teams to drive process optimizations, maintain strict regulatory compliance, and ensure seamless commercial production ramp-ups.

Key Responsibilities Process & Equipment Design:

Design manufacturing processes, procedures, and factory layouts for semi-automated equipment installation, processing, and material handling.

Validation & Qualification:

Develop and execute process and equipment validation protocols, including IQ, OQ, and PQ , as well as test method development and validation.

Root Cause & Corrective Action:

Act as the primary technical escalation point for complex manufacturing issues. Lead root-cause investigations using structured problem-solving tools (5-Why, Fishbone Analysis, Statistical Analysis).

Continuous Improvement:

Lead yield-improvement initiatives, reduce scrap, increase throughput, and optimize labor utilization. Identify and eliminate production bottlenecks.

Documentation & Compliance:

Maintain process specifications, work instructions, and engineering documentation to ensure full compliance with FDA Quality System Regulations (QSR) and

ISO 13485

standards.

Equipment Optimization:

Inspect machinery performance, investigate equipment deficiencies, and partner with equipment suppliers to improve overall equipment capability and reliability.

Design & Automation Collaboration:

Provide technical guidance to design engineering teams to maximize equipment capabilities and support advanced manufacturing and automation initiatives.

Qualifications & Requirements Education:

Bachelor's Degree in Engineering or a related technical field (or foreign equivalent satisfying 8 C.F.R. § 214.2(h)(4)(iii)(A)). An advanced degree is preferred.

Experience:

Minimum of 4+ years of relevant manufacturing experience with a Bachelor's degree, OR Minimum of 2+ years of relevant experience with an Advanced degree.

Industry Experience:

Proven track record supporting medical device manufacturing operations .

Validation Expertise:

Deep hands-on experience with equipment qualification (IQ/OQ/PQ) and manufacturing process validation.

Technical & Statistical Skills:

Strong knowledge of statistical analysis, process control methodologies, and structured problem-solving.

Travel:

Ability to travel up to 50% as required by project milestones. IND2

Pay:

$70.00

• $85.

50 per hour Expected hours: 40.0 per week

Benefits:

Dental insurance Health insurance Vision insurance

Work Location:

In person