Engineering Structures Scimago Jobs in Santa Ana
229 positions found
SUMMARY
Fabcon is seeking a hands-on Manufacturing Engineering Manager to lead production engineering in a high-mix, sheet-metal contract manufacturing environment. This role is critical to Fabcon's operational turnaround and will drive accurate routers, standardized sequences, and strong shop-floor execution to improve efficiency, utilization, and on-time delivery.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Own and standardize manufacturing routers, sequences, and work instructions for sheet metal fabrication and assemblies
• Lead a team of manufacturing engineers and programmers with clear priorities and accountability
• Partner daily with Operations, Scheduling, Quality, and Production Leads to remove bottlenecks and execution gaps
• Improve labor efficiency, utilization, and ERP data accuracy through disciplined engineering practices
• Ensure manufacturability feedback into estimating and quoting
• Drive continuous improvement focused on speed, repeatability, and waste reduction
- Other duties may be assigned
EDUCATION and/or EXPERIENCE
• Bachelor's degree in engineering or related field
• 10+ years' experience in leading a team of engineers, technical professionals, particularly in a production/process facility.
• Strong, practical knowledge of sheet-metal fabrication (laser, punch, press brake, hardware insertion, welding, finishing)
• Proven experience in a contract manufacturing environment
• Hands-on ERP experience (Global Shop Solutions preferred)
• Demonstrated ability to work cross-functionally and lead through influence
LANGUAGE SKILLS
• Ability to read, write, comprehend and communicate in the English language at a 72- percentile using the English-Language Arts Content Standard for California Public Schools. Bilingual ability in Spanish at a business conversational level is preferred.
MATHEMATICAL SKILLS
• The ability to choose the right mathematical methods or formulas to solve a problem.
PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Qualifications:
- HS Diploma / GED
- Familiarity with engineering drawings, hand sketches and rough layouts
- Experience with fabrication, assembly, disassembly, & test of motors, components & assemblies
- Experiencewith: Welding, prototyping of sample parts on lathes, drill presses, vertical mills; all non-CNC
- Highly desirable: 3-phase 480V motors, gearmotors, large hatches, and cycle testing of actuator handles
- Experience assisting with Facilities & Maintenance assistance on internal projects, repairs, and improvements involving air lines, power, inventory & shipping equipment, plant offices and shipping yard
- Must have solid MS Office Skills and Computer skills
Responsibilities:
- Assist in mechanical fabrication and modification of prototype and sample parts
- Mechanical assembly and disassembly of parts, helping to define and set up testing.
- Basic Machining on prototype and sample parts on lathes, drill presses, vertical mills
- Maintenance, service and repair of shop equipment and forklifts
- Assist test engineer with assembly & disassembly of test units. Assist in root cause analysis and
- documentation of dynamometer tests on speed reducers and induction motors (
Full-time
Description
Who We Are
Advanced Cooling Technologies, Inc. (ACT) is a leading provider of thermal management solutions and engineered structures serving Defense, Aerospace, HVAC, Power Electronics, and Medical markets. Recognized as a \"Best Place to Work,\" ACT supports customers including Lockheed Martin, Northrop Grumman, Boeing, NASA, DOD, and DOE.
Job Summary
The Lead Composite Assembly Technician is responsible for assembling, bonding, and finishing composite parts and subassemblies in accordance with engineering drawings, work instructions, and quality standards. In addition to hands-on post-cure operations-including bonding, hardware installation, and final assembly-this role provides daily leadership to assigned technicians to ensure safe, efficient, and high-quality production while supporting workflow coordination, training, and continuous improvement.
Key Responsibilities
Technical
- Assemble, bond, and finish composite parts and subassemblies
- Perform secondary bonding, hardware installation, drilling, trimming, and sanding
- Prepare bonding surfaces and mix/apply structural adhesives per specifications
- Align, fit, and inspect parts to meet dimensional and tolerance requirements
- Follow assembly drawings, travelers, and work instructions
- Complete required manufacturing and quality documentation
- Support rework, repair, and continuous improvement activities
- Adhere to safety, environmental, and quality system requirements
Leadership
- Provide daily direction and task assignments to composite assembly personnel
- Serve as the primary technical resource for troubleshooting bonding and assembly issues
- Train and mentor technicians on proper techniques, safety practices, and quality standards
- Monitor workflow to ensure schedule adherence and efficiency
- Coordinate with production supervisors, engineering, and quality to resolve issues
- Promote a safe, organized, and compliant work environment
- Provide input on performance feedback and serve as acting supervisor when required
Requirements
- Ability to read and interpret engineering and assembly drawings
- Familiarity with hand tools, measuring equipment, and bonding tools
- Understanding of adhesive bonding and surface preparation techniques preferred
- Strong mechanical aptitude and attention to detail
- Ability to work safely with chemicals and adhesives
- Effective communication and leadership skills
- Strong organizational and problem-solving abilities
Education and Experience
- High school diploma or equivalent required
- Prior experience in composite assembly, aerospace manufacturing, or mechanical assembly preferred
- On-the-job training may be provided for entry-level candidates
ACT offers competitive pay, excellent benefits (medical, dental, vision, paid time off, holidays, company-paid life & disability insurance, 401(k) match, and profit-sharing), and a supportive team environment.
ACT is an Equal Opportunity Employer. All qualified applicants will be considered without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other protected characteristic.
ACT participates in E-Verify.
California Applicants: ACT collects personal information for hiring purposes. California residents may have rights under the CCPA/CPRA. Contact HR at [email protected] .
Salary Description
$27-$35/hour
Mechanical Engineer – Aerospace Thermal Management Systems (Integration & Packaging)
Location: Onsite – Irvine CA
Industry: Aerospace & Defense
Duration: 6 months and extendable
Role Overview
We are seeking two highly skilled Mechanical Engineers with experience in the Aerospace & Defense sector to support the development and integration of advanced thermal management subsystems used across military and commercial platforms globally.
This role focuses on mechanical subsystem development from a packaging and integration perspective, including enclosure design and integration of electronic and fluid control components such as pumps, compressors, fans, and valves. The ideal candidate has hands-on experience developing aerospace-grade subsystems within defined volume and interface constraints, ensuring high reliability, environmental robustness, and compliance with industry standards.
These roles will support programs progressing from Preliminary Design Review (PDR) toward Critical Design Review (CDR) and will involve reuse and adaptation of existing product architectures.
Key Responsibilities
- Design and develop mechanical enclosures for aerospace electronic and control subsystems such as thermal management systems and related subsystems
- Package and integrate COTS and custom components into customer-defined volume constraints by integrating components including pumps, compressors, fans, valves, and control electronics
- Develop detailed CAD models, assemblies, and manufacturing drawings (SolidWorks preferred)
- Conduct tolerance analysis, GD&T, stack-up analysis, and design for manufacturability (DFM)
- Support prototype builds, integration activities, testing, and validation
- Implement design considerations to satisfy and qualify the environmental requirements (shock, vibration, temperature, humidity, EMI/EMC interface considerations) per MIL standards.
- Collaborate with electrical, controls, thermal, structural, and systems engineering teams
- Participate in root cause analysis and design refinement
- Ensure compliance with aerospace and defense standards and documentation practices
Required Qualifications
- Bachelor’s degree in mechanical engineering or equivalent.
- 5+ years of experience in Aerospace & Defense mechanical subsystem development
- U.S. Citizen (No Dual Citizenship)
- Strong mechanical packaging and integration experience
- Experience designing enclosures housing electronics and fluid/mechanical components
- Exposure to thermal management systems (ECS, vapor cycle, or liquid cooling preferred but not mandatory)
- Working knowledge of rotating machinery components (fans, compressors, pumps)
- Proficiency in CAD tools (SolidWorks preferred; strong experience in other platforms acceptable)
- Experience with GD&T and tolerance analysis
- Familiarity with aerospace environmental standards (MIL-STD preferred)
- Experience supporting qualification and validation testing
- Strong understanding of materials selection for aerospace applications
- Ability to work in cross-functional engineering teams
Preferred Qualifications
- Experience packaging turbomachinery components within constrained aerospace envelopes
- Exposure to controls systems integration
- Knowledge of vibration isolation and shock mitigation techniques
- Experience supporting PDR/CDR processes
- Familiarity with configuration management and aerospace documentation rigor
- Exposure to FMEA, reliability analysis, and lifecycle support
Battery Pack CAE Model Build Engineer (Safety, Durability & NVH)
Irvine, CA
Onsite
C2C
Must Have Skills: Battery Pack CAE Model Design& develop, ANSA, Meshing,
Preferred: LS-Dyna, Optistruct, Nastran, Abaqus
Role Objective:
Deploy one (1) engineer to provide full vehicle CAE model build and ongoing support for battery pack CAE models across Structural Safety, Durability, and NVH domains. The engineer will build, update, debug, and deliver analysis-ready battery pack models integrated to the vehicle BIW, in accordance with Purchaser-provided standards for numbering, mesh criteria, and joining methodology.
Key Responsibilities / Scope of Services
Develop and maintain battery pack CAE models for each major build release including:
Durability models in Abaqus or OptiStruct template (per Purchaser requirement).
LS-DYNA durability sub-models for the battery system (e.g., Ground Strike, Top Strike).
NVH structural battery models in OptiStruct, including full pack content and BIW integration.
Structural Safety LS-DYNA crash models (homogenized sub-assemblies and/or higher fidelity per program phase).
Build full battery model content as required (structure, plastics, HV network, adhesives, potting) and connect to BIW using subsystem include files and master connection files (including BIW-to-subsystem connection files).
Ensure subsystems are massed per BOM; represent non-modeled content using NSM cards / mass elements and manage trimmed mass and CoG targets as required.
Implement joining representations per Purchaser standards (weld/bond/bolt); represent major bolted joints with solid bolt models and preload where required.
Deliver 0 ms LS-DYNA model debugged to pass error-free model checks; include required instrumentation (force X-sections on major load paths, accelerometers at specified locations).
Support high-fidelity explicit pack models as requested (e.g., cells, cooling plates/features, busbars, vents) and provide de-contented variants when required.
Delivery & Reporting Requirements
Deliver models in compliance with the Purchaser Model Checklist and provide a Seller delivery checklist confirming model run-readiness and documenting any deviations.
Report with each full vehicle CAE model delivery: global energy, mass scaling, and total model mass (as applicable to the domain).
Maintain consistent mesh quality and alignment across domains where required.
Minimum Qualifications (Deployed Engineer)
Demonstrated experience building vehicle CAE models, with battery pack focus preferred.
Proficiency in LS-DYNA, OptiStruct, and Abaqus (as applicable) including model assembly, BIW integration, connections/includes, and debugging.
Strong capability in mesh quality, BOM massing/NSM, joints modeling (weld/bond/bolt), and checklist-driven delivery discipline.
Senior Associate Attorney
Reports to: General Counsel
Essential Functions
- Support and coordinate real estate closings, including review of closing documentation, settlement statements, payoff calculations, title matters, and post-closing issue resolution.
- Work closely with the Legal Department, Compliance, Capital Markets, Servicing, and Asset Management teams to ensure special asset strategies align with Archwest's legal, regulatory, and investor requirements.
- Ensure internal and external compliance across all special asset activities, including adherence to federal and state regulatory requirements (licensing, foreclosure laws, bankruptcy rules, AML, privacy, and ECOA considerations).
- Assist with regulatory examinations, audits, and investor reviews by maintaining audit-ready documentation and responding to inquiries related to special assets and distressed loans.
- Support capital markets initiatives by providing data, analysis, and documentation related to special asset performance, warehouse lending facilities, securitizations, and financing structures.
- Establish and maintain operational reporting to identify performance trends, service-level gaps, risk exposure, and root-cause servicing issues.
- Implement controls, risk-mitigation procedures, and process improvements to reduce legal, operational, and compliance risk.
- Partner with senior management to support long-term planning, strategy development, and execution based on market conditions, regulatory changes, and portfolio performance.
- Oversee policy and procedure development and enhancements related to special assets, loan servicing, workouts, and enforcement actions.
- Manage special assets to achieve the highest and best outcome, including loan resolution, refinance, reinstatement, forbearance, foreclosure, bankruptcy, loss mitigation, liquidation, note sales, and structured workouts.
- Oversee complex real estate–related transactions, including distressed loan workouts, deed-in-lieu transactions, REO strategies, loan modifications, restructurings, and asset dispositions.
- Respond to internal, client, investor, and borrower escalations related to distressed assets and complex transactions.
- Appropriately assess legal, regulatory, and operational risk when making business decisions.
Competencies/Skills
- Strong working knowledge of real estate transactions, loan workouts, and distressed asset resolution.
- Demonstrated understanding of regulatory compliance frameworks affecting mortgage lending and servicing.
- Moderate experience across default servicing and special asset functions, including collections, loss mitigation, foreclosure, bankruptcy, REO, claims, and default compliance.
- Experience supporting or working with warehouse lending facilities and collateral enforcement is a strong plus.
- Strong analytical and financial analysis skills with the ability to evaluate risk and structure solutions.
- Excellent written and verbal communication skills with the ability to interact effectively with attorneys, regulators, investors, borrowers, and internal stakeholders.
- Ability to manage multiple priorities in a fast-paced, highly regulated environment.
- Strong attention to detail with an organized, process-driven mindset.
- Collaborative team player with the ability to work cross-functionally while exercising sound judgment and discretion.
Education and Experience
- Juris Doctor (JD) required.
- Active California Bar license required.
- Bachelor's degree or equivalent professional experience required.
- 3+ years of experience in special assets, mortgage operations, loan asset management, real estate transactions, legal operations, or related financial services.
- Highly preferred experience includes:
- Real estate closings and loan workouts
- Distressed debt and enforcement actions
- Warehouse lending facilities
- Regulatory compliance, audits, or examinations
- Experience working closely with legal, compliance, capital markets, and servicing teams strongly preferred.
Accessibility:
At Archest, we will make reasonable accommodation to enable individuals with disabilities to perform essential functions. Please just let us know by contacting us at
Compensation: salary +annual bonus ($175,000-$225,000)
We have over 50 years of experience in the geotechnical and geological engineering field. With our experts, professional skilled staff, and diverse experience, we offer reliable services in an integrated, efficient, and cost-effective service to clients in the public and private sectors. Our services include Geotechnical Engineering, Geotechnical Engineering Laboratory Materials Testing, Engineering Geology, and Environmental Engineering.
We plan to expand geotechnical services and uphold our commitment to quality and client satisfaction. We are growing and looking for an experienced and motivated Project Engineer to join our team.
About the Job:
As a Project Engineer, you will be involved in the geotechnical and geological aspects of a wide variety of projects. You will play a crucial role which includes daily project management, performing and/or leading field investigations, engineering analysis, calculations, and recommendations, design, and development of plans and specifications, observation and inspection, and the writing/preparation, and review of related reports for the services provided. Review plans and drawings to ensure compliance with the project specifications. Prepare proposals and cost estimates, track and evaluate project progress and budgets, and recommend changes. Research and resolve design and construction problems. Assign, review, and evaluate laboratory or field data for report inclusion. Apply sound engineering principles and be able to communicate complex engineering issues and concepts to technical and non-technical clients and project teams.
Primary Job Duties:
• Conduct geotechnical (preliminary and forensics) and geological investigations
• Perform field inspections and testing as required for construction projects
• Analyze data and prepare geotechnical reports on soil conditions, stability, foundation design, etc.
• Collaborate with architects, engineers, and construction teams to develop effective solutions
• Provide technical guidance on geological and geotechnical related issues throughout the project lifecycle
• Ensure compliance with industry standards, regulations, and safety protocols
• Project management from the planning phase to the completion of the project
• Conduct plan reviews
• Generate cost proposals
• Participate in project meetings and communicate effectively with owners, designers and project authorities
Job Qualifications (Education, Experience, and Skills):
• Bachelor’s Degree in Civil Engineering with a focus in Geotechnical Engineering
• Minimum of 2 years of relevant professional experience
• Professional Engineer or Engineer-in-Training Certification in the state of California.
• Strong analytical and critical thinking skills and a sound technical background in soil and rock mechanics
• Attention to detail, dedication to quality and accuracy
• Experience with various commercial geotechnical software
• Strong written and oral communication skills
• Ability to work independently or as part of a team
• Working knowledge of standard business software including Microsoft Word, Excel, and PowerPoint
Key Competencies:
• Strong knowledge of geotechnical and geological engineering principles and practices
• Knowledge with the local and statewide such as the California Building Code, Los Angeles Building, California Residential Code
• Proficiency in construction inspection and management
• Ability to analyze data and interpret results
• Proficient in using software and other engineering tools related to the discipline.
• Excellent problem-solving skills and attention to detail
• Strong communication skills to collaborate with multidisciplinary teams
• Ability to read and interpret schematics and construction drawings
You will act as the Staff Mechanical Engineering Owner's Representative with technical expertise for mechanical engineering issues, design management of in-house and outside resources, code compliance, Disney design standards, documentation, specifications, and life cycle cost analysis for best value. This role also involves close collaboration with other engineering disciplines and multiple Disney project teams including FAM, WDI, Entertainment, and Operations.
You will report to the Senior Manager for MEP Engineering with DLR Architecture & Facilities Engineering.
What You Will Do
* Act as Owner's Representative on projects from concept through construction at the Disneyland Resort. Project types will include shops, rides, hotels, shows, maintenance facilities, and nearly any built facility and area development found on our property.
* Manage the design and development of contract documents of projects with in-house and outside resources to meet project scopes, schedules and budgets.
* Develop concepts and Request for Proposals (RFP)s.
* Attend, participate, and problem solve during site visits from concept through construction.
* Review drawings and specifications and ensure that all projects are designed and executed to applicable codes and statutes
* Work with stakeholders to provide civil engineering resources to develop project scope including design, planning and code compliance for estimation and feasibility.
* Resolve design issues creatively and thoroughly coordinating design with other disciplines.
* Develop clear technical analyses and recommend frameworks to inform executive review and approval.
* Partner with internal teams to develop, maintain, communicate, and enforce Walt Disney Company design guidelines, standards, master specifications, and details.
* As the owner's representative, you'll review with a focus on constructability, efficiency, and long-term maintainability.
* Liaison with City officials and external agencies to ensure project scope and implementation is coordinated and compliant with external requirements.
* Research Record Drawings in Disneyland Archives.
* Perform field work to investigate and assess mechanical related infrastructure in the Resort.
* Independently review new and existing design drawings and calculations.
* Review shop drawing submittals and respond to vendor requests for information per Resort standards.
* Coordinate design activities and monitor field installations and demolition work that comply with specifications and code requirements.
* Perform reviews of existing infrastructure: propose upgrades and replacements, present findings and recommendations.
* Serve as Engineer of Record on assigned projects, including signing and sealing construction documents when required.
* Design with focus on constructability, efficiency, and long-term maintainability.
* Expedite the receipt of sample submittals required for final design approval.
* Participate in weekly design coordination meetings and prioritize items to minimize schedule impacts.
* Assist Project and Design Managers to resolve design compliance issues relating to Projects requirements. Validate that all Item Specifications are consistent with products installed before archiving manuals.
* Support Executive Design Reviews by contributing technical content, analysis, and coordination as requested by Project or Design Management.
What We Look For
* 10+ years of experience in mechanical engineering design, HVAC/DX/VRF/CHW applications, central plant development and operational guidance, hydraulics, hydronics, compressed air, overall kitchen designs and implementation.
* Ability to support project partners in procurement and construction.
* Experience with AutoCAD, Revit, ACC, and other engineering-based software.
* Working knowledge of both National and Local Standards and Codes.
Required Education and Licensure
* BS Mechanical Engineering or related field from an ABET accredited university.
* Current registration as a Professional Engineer in the State of California in good standing.
#DXMedia #DXFOS #LI-YW1
Additional Information
Benefits and Perks: Disney offers a rewards package to help you live your best life. This includes health and savings benefits, educational opportunities, and special extras that only Disney can provide. Learn more about our benefits and perks at ( ) .
The hiring range for this position in Anaheim, CA is $126,800.00 to $154,800.00 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographical region, job-related knowledge, skills, and experience among other factors. A bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.
"We create happiness." That's our motto at Disney Experiences. At Disney, you'll help inspire magic by enabling our teams to push the limits of entertainment and create innovative built environments. You will collaborate to develop ideas/thoughts into physical reality! The Architecture & Facilities Engineering (A&FE) team is looking for a Staff Mechanical Engineer to support the development and sustainment of projects we support throughout the Disneyland Resort. Our department supports a wide range of project types including Attractions, Maintenance, Foods, Merchandise, and Entertainment. Projects range from minor renovations to new facilities. You will also support immediate response efforts with reactionary projects.
You will act as the Staff Mechanical Engineering Owner's Representative with technical expertise for mechanical engineering issues, design management of in-house and outside resources, code compliance, Disney design standards, documentation, specifications, and life cycle cost analysis for best value. This role also involves close collaboration with other engineering disciplines and multiple Disney project teams including FAM, WDI, Entertainment, and Operations.
You will report to the Senior Manager for MEP Engineering with DLR Architecture & Facilities Engineering.
What You Will Do
- Act as Owner's Representative on projects from concept through construction at the Disneyland Resort. Project types will include shops, rides, hotels, shows, maintenance facilities, and nearly any built facility and area development found on our property.
- Manage the design and development of contract documents of projects with in-house and outside resources to meet project scopes, schedules and budgets.
- Develop concepts and Request for Proposals (RFP)s.
- Attend, participate, and problem solve during site visits from concept through construction.
- Review drawings and specifications and ensure that all projects are designed and executed to applicable codes and statutes
- Work with stakeholders to provide civil engineering resources to develop project scope including design, planning and code compliance for estimation and feasibility.
- Resolve design issues creatively and thoroughly coordinating design with other disciplines.
- Develop clear technical analyses and recommend frameworks to inform executive review and approval.
- Partner with internal teams to develop, maintain, communicate, and enforce Walt Disney Company design guidelines, standards, master specifications, and details.
- As the owner's representative, you'll review with a focus on constructability, efficiency, and long-term maintainability.
- Liaison with City officials and external agencies to ensure project scope and implementation is coordinated and compliant with external requirements.
- Research Record Drawings in Disneyland Archives.
- Perform field work to investigate and assess mechanical related infrastructure in the Resort.
- Independently review new and existing design drawings and calculations.
- Review shop drawing submittals and respond to vendor requests for information per Resort standards.
- Coordinate design activities and monitor field installations and demolition work that comply with specifications and code requirements.
- Perform reviews of existing infrastructure: propose upgrades and replacements, present findings and recommendations.
- Serve as Engineer of Record on assigned projects, including signing and sealing construction documents when required.
- Design with focus on constructability, efficiency, and long-term maintainability.
- Expedite the receipt of sample submittals required for final design approval.
- Participate in weekly design coordination meetings and prioritize items to minimize schedule impacts.
- Assist Project and Design Managers to resolve design compliance issues relating to Projects requirements. Validate that all Item Specifications are consistent with products installed before archiving manuals.
- Support Executive Design Reviews by contributing technical content, analysis, and coordination as requested by Project or Design Management.
What We Look For
- 10+ years of experience in mechanical engineering design, HVAC/DX/VRF/CHW applications, central plant development and operational guidance, hydraulics, hydronics, compressed air, overall kitchen designs and implementation.
- Ability to support project partners in procurement and construction.
- Experience with AutoCAD, Revit, ACC, and other engineering-based software.
- Working knowledge of both National and Local Standards and Codes.
Required Education and Licensure
- BS Mechanical Engineering or related field from an ABET accredited university.
- Current registration as a Professional Engineer in the State of California in good standing.
#DXMedia #DXFOS #LI-YW1
Additional Information
Benefits and Perks: Disney offers a rewards package to help you live your best life. This includes health and savings benefits, educational opportunities, and special extras that only Disney can provide. Learn more about our benefits and perks at .
Job Title: R&D Test Engineer
Location: Irvine, CA
Employment Type: Full-Time
Position Overview
We are seeking R&D Test Engineers to support the development and verification of innovative drug delivery and medical device products. The selected candidates will contribute to verification and validation activities, test method development, and product testing to ensure compliance with regulatory and internal quality standards.
This role involves working closely with cross-functional teams including R&D, Quality, Manufacturing, and Regulatory Affairs to support product development, verification strategies, and root cause investigations.
Key Responsibilities
- Assist in the development and testing of innovative drug delivery products.
- Define and execute verification strategies, including development of verification plans, protocols, records, and reports.
- Develop scientifically justified sample size strategies in compliance with internal and regulatory requirements.
- Design and execute engineering and verification test procedures.
- Prepare test protocols and documentation, maintain accurate laboratory notebooks, and present results to cross-functional teams.
- Analyze test data and provide technical insights and recommendations.
- Lead or support root cause investigations and implement issue resolutions.
- Define, develop, and validate test methods for product verification.
- Recommend design, process, or project improvements to enhance product performance and development efficiency.
- Ensure compliance with company policies, regulatory standards, and safety procedures.
- Review and evaluate design changes for technical and regulatory compliance.
- Conduct tests to determine physical and mechanical characteristics of materials for quality control, process control, and product development.
- Perform technical tasks according to quality and functional standards.
Required Qualifications
R&D Test Engineer
- Experience in R&D testing, product development, or verification within engineering environments.
- Strong experience in verification planning, protocol development, and testing execution.
- Demonstrated ability to lead root cause investigations and technical problem-solving.
- Experience working in regulated industries (medical devices preferred).
- Strong technical documentation and cross-functional communication skills.
- experience in engineering testing, product development, or laboratory environments.
- Basic knowledge of engineering test methods and verification processes.
- Ability to perform testing, data analysis, and documentation under supervision.
- Strong analytical and problem-solving skills.
Preferred Skills & Tools
Experience with the following tools and technologies is preferred:
Testing & Lab Equipment
- Zwick or Instron testing systems
- Flow measurement equipment
- Viscometers
- Climate chambers
- 3D printing technologies
Engineering & Data Tools
- SolidWorks
- Minitab
- Electronic Lab Notebook (ELN)
Project & Requirements Management
- Microsoft Project
- Laboratory Information Management Systems (LIMS) such as LinkUS
- Requirements and Risk Management tools such as DOORS or Cockpit