Top 13 senior process engineer Jobs in el cajon ca

Senior Process Quality Engineer
Primary Talent Partners —San Diego, CA
- $54 - $64 an hour
- Contract
- 5 years
- Master's degree
- Mentoring
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3d
Senior Manufacturing Process Engineer
Oura —San Diego, CA
- Hybrid work
- English
- Travel
- Senior level
Sr. Packaging Development Manager
Monster Energy —San Diego, CA
- $114,000 - $152,000 a year
- 3 years
- Continuous improvement
- Senior level
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Senior Process Engineer
AEMI Holdings, LLC —San Diego, CA
- $115,000 - $130,000 a year
- Full-time
- Engineering
- Ability to climb stairs
- In-person
- Health insurance
- Dental insurance
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Senior Engineer, Process Development Engineer
Synchron Inc. —San Diego, CA
- $140,000 - $200,000 a year
- Full-time
- 5 years
- Analysis skills
- Senior level
- Commuter assistance
- Disability insurance
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Sr. Quality Engineer
Axillon Aerospace, Inc. —San Diego, CA
- $120,000 - $130,000 a year
- 7 years
- Writing skills
- Engineering
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Senior Supplier Technical Engineer
Solar Turbines —San Diego, CA
- $112,704 - $169,056 a year
- ERP systems
- Pass drug screening
- English
- Health savings account
- Paid holidays
9d
Senior Principal Process Control Engineer
Solar Turbines —San Diego, CA
- Full-time
- 7 years
- Engineering
- Pass drug screening
- Health savings account
- Paid holidays

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Process Engineer - Mechanical
TTM Technologies —San Diego, CA
Must comply with TTM Export Control Policies and Procedures and all applicable laws including ITAR, EAR and OFAC including but not limited to: a) being able to…
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Senior Process Quality Engineer
Primary Talent Partners —San Diego, CA
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related engineering field AND 7+ years of experience in process development,…
$54 - $64 an hour
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3d

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Anduril Industries —Columbus, OH
Architect the requirements and roadmaps for next-generation digital manufacturing tools to improve manufacturing design, analysis, and production efficiency.
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Senior Process Quality Engineer

Primary Talent Partners -
San Diego, CA

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Job Details

Contract
$54 - $64 an hour
3 days ago

Qualifications

Incident investigation techniques for hazard identification
Production data analysis
Hypothesis testing
Engineering development testing
ISO standards
Quality control statistical data analysis
Design of manufacturing processes
Statistical Process Control
Production risk assessment
Reliability analysis
Corrective and preventive actions (CAPA)
GMP
Minitab
Collaboration with product development teams
Vendor compliance management
Policy & process development
Production validation processes
Medical device manufacturing facility experience
Inferential statistics
Design failure mode and effects analysis (DFMEA)
Supplier development
Mentoring
Regulatory/legal compliance standards in production
Collaboration with manufacturing teams
Regression analysis
Design for manufacturability (DFM)
Design controls
Biomedical regulatory compliance
Biomedical manufacturing processes
Test validation method

Full Job Description

Primary Talent Partners has a new contract opening for a Senior Process Quality Engineer with our healthcare client in San Diego, CA. This is a 12-month contract with a potential for extension.

Pay: $54.00 - $64.00/hr; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment. Candidates must be legally authorized to work in the United States and must be able to sit on Primary Talent Partners W2 without sponsorship.

Description:
Design Quality Engineer — Process Development to support new product introduction (NPI) and production scale-up activities within the diabetes medical device space. This individual will drive process validation strategies, lead process risk management (PFMEA), and serve as a critical crossfunctional liaison between internal Supplier Quality, R&D, Contract Manufacturers, and NPI teams.

The ideal candidate brings deep expertise in process development, FMEA methodologies, and regulatory compliance —A proven track record of resolving critical production issues during scale-up and mentoring engineering teams is essential.

Process Development & Validation

Develop P-diagrams, Input-Process-Output (IPO) matrices, process characterizations, and test method validation (TMV) strategies for NPI programs.
Author and manage Master Validation documents (IQ/OQ/PQ/EQV/TMV) for new product introductions and production scale-up.
Apply methodologies including Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Manufacturing Assembly (DFMA), and Cell Operating System (COS).
Drive risk mitigation approaches by integrating qualification parts early in process development phases

Process Risk Management & Risk Navigation

Facilitate and generate Process Failure Modes Effects Analysis (PFMEA) documents for manufacturing processes during NPI and scale-up.
Maintain strong working knowledge of design risk documentation (RAD, DFMEA, HRA) to critically analyze process-related failures and identify gaps.
Recognize when process findings have design risk implications and escalate appropriately to Design Quality Assurance (DQA) partners for design risk assessment decisions.
Leverage understanding of risk documentation during root cause investigations and critical analyses to ensure comprehensive disposition.
Conduct thorough root cause investigations using A3 Problem Solving methodology, fishbone diagrams, 5-Why analysis, and brainstorming techniques

Cross-Functional Engagement & Collaboration

Serve as the primary quality interface between internal Supplier Quality Engineering (SQE), R&D cross-functional teams, Contract Manufacturers, and NPI program teams
Facilitate regular cadence of alignment discussions with Supplier Quality and vendors to implement updated control plans, inspection criteria, and risk documentation.
Collaborate with R&D teams to translate design intent into manufacturable process parameters during design transfer
Partner with NPI groups to ensure seamless transition from development builds through production qualification and commercial readiness.
Ensure alignment between contract manufacturers and internal teams on deliverables, expectations, and quality standards.
Bridge QMS gaps between contract manufacturing partners and internal quality systems, standardizing documentation templates and expectations.
Direct comprehensive drawing reviews with cross-functional partners ensuring all Critical Dimensions are accounted for incoming and in-process inspections.

Production Scale-Up Support & Crisis Management

Lead cross-functional teams through high-pressure production holds and scale-up challenges during NPI commercialization.
Conduct root cause investigations (A3 methodology) and implement Corrective and Preventive Actions (CAPA).
Strategize and guide engineering teams to deploy effective investigation approaches for supplier and manufacturing issues.
Proactively identify production risks during scale-up and drive containment/resolution before they impact launch timelines.

Statistical Analysis & Data-Driven Decision Making

Perform statistical analyses including hypothesis testing, confidence and tolerance intervals, regression, capability analysis, DOEs, and GR&R using Minitab.
Utilize statistical process control (SPC), I-MR charts, Box plots, and Normality & No

Required Skills & Qualifications:

4+ years applying DRM, DFSS, DFMA, and COS methodologies in medical device process development
4+ years facilitating and generating PFMEA documents; strong working knowledge of DFMEA and design risk documentation (RAD, HRA) sufficient to identify
gaps and escalate appropriately
4+ years developing process parameters, DOEs, P-diagrams/IPO matrices, process characterizations, and process validation strategies (IQ/OQ/PQ/TMV)
4+ years performing statistical analysis (hypothesis testing, confidence/tolerance intervals, regression, capability analysis, DOEs, GR&R) in Minitab
4+ years working within FDA QSR, ISO 13485, ISO 14971, ISO 11135, ISO 11737, and EU MDR regulatory frameworks
4+ years coordinating Design Control, Design Verification, Process Validation, root cause investigations, and CAPA activities
Demonstrated experience collaborating cross-functionally with Supplier Quality, R&D, Contract Manufacturers, and NPI teams in a matrixed environment
Demonstrated experience utilizing Good Manufacturing Practices (GMP) and FMECA

Preferred Qualifications:

Experience with CGM (Continuous Glucose Monitoring) sensors or insulin pump systems
Proven track record resolving production holds during NPI commercialization and scale-up
Experience managing design transfer and production scale-up activities with contract manufacturers.
Experience serving as the quality "bridge " between multiple external partners and internal stakeholders
Experience with problem-solving methodology
CQE (Certified Quality Engineer) or Six Sigma Black Belt certification
Familiarity with automated manufacturing lines and assembly-level process optimization
4+ years applying DRM, DFSS, DFMA, and COS methodologies in medical device process development
4+ years facilitating and generating PFMEA documents; strong working knowledge of DFMEA and design risk documentation (RAD, HRA) sufficient to identify
gaps and escalate appropriately
4+ years developing process parameters, DOEs, P-diagrams/IPO matrices, process characterizations, and process validation strategies (IQ/OQ/PQ/TMV)
4+ years performing statistical analysis (hypothesis testing, confidence/tolerance intervals, regression, capability analysis, DOEs, GR&R) in Minitab
4+ years working within FDA QSR, ISO 13485, ISO 14971, ISO 11135, ISO 11737, and EU MDR regulatory frameworks
4+ years coordinating Design Control, Design Verification, Process Validation, root cause investigations, and CAPA activities
Demonstrated experience collaborating cross-functionally with Supplier Quality, R&D, Contract Manufacturers, and NPI teams in a matrixed environment
Demonstrated experience utilizing Good Manufacturing Practices (GMP) and FMECA

Required:

Master's degree in Mechanical Engineering, Biomedical Engineering, or related field AND 5+ years of experience in process development, manufacturing, or quality engineering for medical devices OR
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related engineering field AND 7+ years of experience in process development, manufacturing, or quality engineering for medical devices

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at [email protected]

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senior process engineer jobs in el cajon ca

Senior Process Quality Engineer

Senior Manufacturing Process Engineer

Sr. Packaging Development Manager

Senior Process Engineer

Senior Engineer, Process Development Engineer

Sr. Quality Engineer

Senior Supplier Technical Engineer

Senior Principal Process Control Engineer

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