Engineering Jobs in Costa Mesa, CA

*Position only available on-site in Irvine, CA*

Job Summary:

We are seeking a highly experienced Clinical Studies Coordinator to lead and execute end-to-end clinical studies supporting FDA submissions (510(k)), pilot and feasibility studies, post-market clinical follow-up, and real-world evidence generation.

This role is hands-on, operational, and strategic. The ideal candidate has deep experience managing medical device and digital health clinical studies, working directly with FDA-facing documentation, IRBs, investigators, CROs, and internal regulatory, engineering, and product teams.

This position plays a critical role in de-risking regulatory submissions, ensuring GCP compliance, and translating clinical evidence into successful regulatory and commercial outcomes.

Key Responsibilities:

• Lead the planning, coordination, and execution of clinical studies, including:
• Pilot/feasibility studies
• IDE-exempt and IDE-supporting studies
• Pivotal and non-pivotal studies for FDA 510(k) submissions
• Post-market surveillance (PMS) and post-market clinical follow-up (PMCF)
• Real-world evidence (RWE) and usability studies
• Develop and manage study timelines, milestones, and deliverables
• Ensure studies are conducted in compliance with GCP,FDA regulations, ISO 14155 and other applicable standards.
• Prepare, review, and maintain clinical documentation for regulatory submissions, including:
• Clinical Study Plans (CSPs)
• Protocols and amendments
• Informed Consent Forms (ICFs)
• Statistical Analysis Plans (SAPs) (in collaboration with biostatistics)
• Clinical Study Reports (CSRs)
• Ensure audit-ready clinical documentation at all times

Other Responsibilities:

• Support subject recruitment and enrollment activities
• Conduct blood draws on study subjects.
• Process blood samples.
• Initiate IV's when the MD is unavailable.
• Supervise the maintenance of laboratory equipment, including calibration records.
• Maintain clinical staff training documentation.
• Perform other duties or special projects as requested.

Minimum Qualifications and Experience:

• 7 – 10 years of related experience or equivalent combination of education and experience.
• Excellent communication skills (both written and oral).
• Knowledge of clinical databases and data management systems
• Ability to be an integral part of an innovative, fast-paced product development team.
• Ability to manage multiple concurrent studies is essential
• LVN with IV training certificate or RN.

Preferred Qualifications:

• Bachelor's degree in Life Sciences, Biostatistics, Health Informatics, Biomedical Engineering
• Experience with clinical studies and interfacing with IRB.
• Clinical research certifications

Physical requirements/Work Environment:

This position primarily works in an office as well as laboratory environment. It requires frequent sitting, standing and walking. Work in a lab involves potential exposure to blood borne pathogens, as well as needles. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings, walking in the facilities, or processing tissue samples, blood, etc. Some local travel is necessary so the ability to operate a motor vehicle and maintain a valid Driver's license is required. Some travel to clinical sites might be required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

Workers Compensation Claim Manager

Property & Casualty Insurance

The manager oversees a team of Claim Specialists who address claims of varying complexities within the department. This role involves tracking claim trends and regularly reporting findings to department leadership, along with action plans to mitigate any negative trends. Candidates residing in Pacific Standard Time regions are highly preferred. A deep understanding of California Workers' Compensation statutes is essential. The manager will direct policies and procedures to ensure that claim handling aligns with the company's best practices, as well as all relevant legal and regulatory standards.

Collaboration with the Assistant Vice President is a key aspect, focusing on the planning and establishment of regional business goals. Working alongside risk engineering, underwriting, account executives, vendor management, and legal teams, the manager will address trends that could affect claims costs and develop guidelines that support the department's and company's objectives. Technical support should be provided to claims specialists, drawing from industry publications, seminars, and various resources to remain current on essential updates.

Staying informed about recent legal rulings and trends by reviewing case law is also critical. Ensuring a competent claims staff is vital for the timely and equitable resolution of claims based on applicable contracts, state regulations, and company policies. Coverage issues will be identified, including a review of all coverage evaluation letters. The manager will approve recommendations for case reserves and oversee the adequacy of reserves for claims managed by the team. Guidance in claim negotiations and extending settlement authority to Claims Specialists is essential, as is recruiting, mentoring, and retaining skilled staff. Developing and training direct reports is important to maximize their growth and success, while also addressing any performance issues to meet both departmental and individual goals.

Setting, executing, and monitoring regional office claims objectives in alignment with the company's mission is crucial, along with a willingness to participate in special projects beyond standard duties. Engaging with current and potential customers about the company's claims capabilities and their specific needs is also required.

Candidates should have over eight years in WC Claims supervision or management roles, with substantial experience in California jurisdiction. A bachelor's degree or its equivalent is mandatory, alongside strong verbal and written communication skills. Proficiency in the Microsoft Office suite and Lotus Notes is also necessary.

About Company:

Who Are We?

ELIQUENT Life Sciences is a leading global consulting group delivering regulatory affairs, pharmacovigilance, quality, and compliance solutions that support pharmaceutical, biotechnology, medical device, and combination product companies across therapeutic modalities, phase-based pathways, and major global markets.

Why explore your future at ELIQUENT?

ELIQUENT Life Sciences is a trusted global consulting firm helping life sciences companies navigate regulatory complexity and bring breakthrough therapies to market. Founded by former regulators and industry experts, we offer end-to-end support in regulatory affairs, pharmacovigilance, and quality compliance. Our team is driven by a shared mission to improve global health through innovation, collaboration, and integrity. At ELIQUENT, you will be part of a purpose-led organization where your expertise contributes to meaningful impact and your growth is supported every step of the way.

About the Role:

The Process Validation Engineer plays a critical role in ensuring that manufacturing processes consistently produce products that meet predetermined quality standards and regulatory requirements. This position involves designing, executing, and documenting validation protocols to confirm that processes operate within defined parameters and yield reliable, reproducible results. The engineer collaborates closely with cross-functional teams including manufacturing, quality assurance, and regulatory affairs to identify process risks and implement corrective actions. By analyzing process data and trends, the engineer supports continuous improvement initiatives that enhance process efficiency and product quality. Ultimately, this role ensures compliance with industry standards and contributes to the successful commercialization of products within the United States market.

Minimum Qualifications:

• Bachelor's degree in Engineering, Science, or a related technical field.
• 3+ years of experience in process validation within a regulated manufacturing environment.
• Strong knowledge of validation principles, methodologies, and regulatory requirements (e.g., FDA, cGMP, ISO).
• Experience with statistical analysis and process capability studies.
• Excellent written and verbal communication skills.

Preferred Qualifications:

• Master's degree in Engineering, Quality Assurance, or related discipline.
• Experience in the pharmaceutical, biotechnology, or medical device industries.
• Familiarity with automation systems and computerized system validation (CSV).
• Certification in Quality or Validation (e.g., ASQ Certified Quality Engineer).
• Proficiency with data analysis software such as Minitab or JMP.

Responsibilities:

• Develop, review, and execute process validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Collaborate with manufacturing and quality teams to identify critical process parameters and quality attributes.
• Analyze process data to assess process capability and identify areas for improvement.
• Prepare detailed validation reports and maintain comprehensive documentation in compliance with regulatory standards such as FDA and ISO.
• Support investigations related to process deviations, non-conformances, and implement corrective and preventive actions (CAPA).
• Participate in risk assessments and process design reviews to ensure robust and compliant manufacturing processes.
• Train and mentor manufacturing personnel on process validation requirements and best practices.

Skills:

The Process Validation Engineer utilizes analytical skills daily to interpret complex process data and ensure manufacturing consistency. Strong communication skills are essential for collaborating with cross-functional teams and documenting validation activities clearly and accurately. Technical expertise in validation protocols and regulatory standards guides the development and execution of robust validation plans. Problem-solving skills are applied to investigate deviations and implement effective corrective actions. Additionally, proficiency with statistical tools and software supports data-driven decision-making and continuous process improvement.

Mechanical Engineer – Aerospace Turbomachinery Systems

Location: Onsite – Irvine CA

Industry: Aerospace & Defense

Citizenship Requirement: U.S. Citizen (No Dual Citizenship)

Role Overview

We are seeking a Mechanical Engineer with strong turbomachinery design experience to support the development of advanced aerospace thermal management subsystems used across military and commercial platforms globally.

This role focuses on the design and development of rotating machinery, including compressors, pumps, and fans integrated within aerospace thermal systems. The ideal candidate has hands-on experience designing turbomachinery components from concept through validation, with strong grounding in aerodynamics, CFD, structural integrity, and high-speed rotating equipment design.

These programs are entering early development phases prior to Preliminary Design Review (PDR), requiring strong technical leadership in turbomachinery architecture, performance prediction, and mechanical robustness.

Key Responsibilities

• Design and develop mechanical enclosures and subsystems incorporating turbomachinery components
• Lead the mechanical design and development of turbomachinery components including compressors, pumps, and fans
• Perform aerodynamic design and optimization of rotating components
• Conduct or support CFD analysis for flow performance and efficiency validation
• Perform structural analysis of rotating components, including stress, fatigue, and rotor dynamics considerations
• Support bearing selection, shaft design, housing integration, and sealing strategies
• Define performance requirements and conduct trade studies during early-phase system architecture
• Support prototype builds, performance testing, and validation activities
• Ensure designs meet aerospace environmental requirements (shock, vibration, temperature, altitude)
• Collaborate with thermal, systems, controls, and packaging teams for subsystem integration
• Develop detailed CAD models and manufacturing drawings (SolidWorks preferred)
• Participate in root cause analysis, performance troubleshooting, and design improvements
• Ensure compliance with aerospace and defense standards and documentation practices

Required Qualifications

• U.S. Citizen (No Dual Citizenship)
• Bachelor's degree in mechanical engineering or equivalent.
• 7+ years of experience in Aerospace & Defense mechanical subsystem development
• Direct turbomachinery design experience (compressors, pumps, fans, or similar rotating machinery)
• Experience with aerodynamic design principles and performance prediction
• Working knowledge of CFD tools and analysis interpretation
• Experience with structural analysis of rotating components (stress, fatigue, rotor dynamics fundamentals)
• Proficiency in CAD tools (SolidWorks preferred; strong experience in other platforms acceptable)
• Experience supporting early development phases and design reviews
• Familiarity with aerospace environmental standards (MIL-STD preferred)

Preferred Qualifications

• Experience designing turbomachinery for thermal management or Environmental Control Systems
• Familiarity with high-speed electric motor integration
• Experience with balancing, vibration mitigation, and rotating system qualification
• Exposure to FEA tools for structural validation
• Experience progressing programs through PDR/CDR

Company Description

VOXELPLA is one of the leading 3D printing filament manufacturers in the USA. We focus on developing high-performance thermoplastic filaments for 3D printing (PLA, PETG, ASA, ABS, and TPE). Our mission is to empower makers and innovators with materials they can rely on.

Role Description

New graduates are welcome to apply. This is a full-time, on-site role for a full-cycle B2B Sales Representative located in Garden Grove, CA. The primary responsibilities include expanding our B2B business, generating leads, managing existing accounts, developing new client relationships, and maintaining long-term partnerships. The role also involves providing exceptional customer service, effectively communicating with clients, presenting solutions, and meeting sales targets. The Account Executive will collaborate with internal teams to meet the needs of customers and support business objectives.

We offer comprehensive benefits and lucrative performance-based bonuses.

Qualifications

• Proven skills in B2B Sales and Account Management
• Excellent Communication and relationship-building abilities
• Strong Customer Service expertise and client-focused approach
• Sales-driven mindset with a track record of meeting or exceeding sales goals
• Exceptional organizational skills and time management abilities
• Bachelor’s degree or higher in Engineering, Business Administration, Marketing, Sales, or a related field is preferred

Nice to Have

• Passion for 3D printing, open-source hardware, or materials innovation

Our client, a well-funded, video collaboration technology company is hiring an Account Executive to help expand its footprint across the media and entertainment landscape. This is a rare opportunity to work directly alongside a repeat entrepreneur who previously scaled a startup to a global multimillion dollar company, paired with a deeply technical co-founder with 25+ years in telecommunications and video innovation.

The company sits at the intersection of premium video technology and human connection, delivering high-fidelity, broadcast-grade collaboration experiences for organizations where quality, presence, and reliability matter. The team is building a next-generation platform designed to make digital collaboration feel more natural, immersive, and dependable.

The Opportunity

This role is ideal for a motivated, consultative seller who enjoys building pipeline, owning deals end-to-end, and working closely with founders in an early-stage growth environment. You’ll focus selling into media and entertainment organizations (ideally brand side experience), engaging senior decision-makers and helping them solve real operational and creative collaboration challenges through modern video infrastructure.

What You’ll Be Responsible For

• Driving new revenue across media and entertainment accounts
• Owning the full sales cycle from outbound prospecting through close
• Closing mid-market deals typically in the $40K–$60K ACV range - will go upmarket
• 50/50 focus on net new vs warm leads
• Running discovery, demos, and solution mapping conversations with executive stakeholders
• Navigating multi-stakeholder buying groups and technical evaluators
• Applying a consultative sales approach tied to business outcomes
• Maintaining disciplined pipeline and forecast accuracy
• Feeding structured market and buyer insight back to product and leadership

Core Experience

• 5+ years of B2B SaaS sales experience
• Consistent track record closing mid-market deals ($40K–$100K ACV)
• Experience selling into executive and C-suite buyers
• Exposure to media, entertainment, broadcast, creative, or production environments
• Comfortable operating in early-stage or scaling companies where structure is evolving

Selling Style & Traits

• True hunter mentality with strong self-sourcing habits
• Consultative and solutions-oriented rather than purely transactional
• Comfortable with ambiguity and high ownership
• Proactive, resourceful, and execution-focused
• Strong communicator with executive presence
• Curious, coachable, and continuously improving craft

What Makes This Role Attractive

• Direct access to experienced, product-driven founders
• OTE guarantee
• Real influence on early go-to-market motion and customer strategy
• Equity
• Benefits package included
• High product quality bar and engineering credibility
• Opportunity to help shape how a category-defining collaboration platform scales
• Growth upside as the company grows

HCLTech is looking for a highly talented and self- motivated Senior Design Quality Engineer to join it in advancing the technological world through innovation and creativity.

Job Title: Senior Design Quality Engineer

Job ID: 79890

Position Type: Full-time with HCLTech

Location: Irvine, CA

Role/Responsibilities:

Client is seeking a seasoned Senior Design Quality Engineer to support quality engineering activities for released products, ensuring compliance with regulatory standards and internal procedures. This role involves cross-functional collaboration to manage product risks, support validation efforts, and drive continuous improvement in design and manufacturing processes.

Key Responsibilities:

• Ensure quality engineering activities for released products align with regulatory and internal standards.
• Collaborate with cross-functional teams to develop and maintain product risk management documentation:
• Risk Management Plans
• Risk Assessments
• Design Failure Mode and Effects Analysis (DFMEA)
• Risk Management Reports
• Support the development and execution of:
• Verification & Validation (V&V) plans, protocols, and reports
• Test Method Validation
• Process validation activities (PFMEA, IQ, OQ, PQ)
• Utilize statistical tools (e.g., Minitab) for data analysis and decision-making.
• Oversee product testing and analysis to ensure compliance with applicable standards.
• Apply Design Control principles to support sustaining engineering efforts, including design updates and product enhancements.
• Resolve quality issues, manage design changes, and assess risks in collaboration with engineering, manufacturing, and quality teams.
• Proactively identify and mitigate product risks using risk management techniques.
• Employ structured problem-solving methodologies to address product and process challenges.
• Communicate findings effectively through presentations, technical reports, and cross-functional collaboration.

Pay and Benefits

Pay Range Minimum: $42.78 per hour

Pay Range Maximum: $50.00 per hour

HCL is an equal opportunity employer, committed to providing equal employment opportunities to all applicants and employees regardless of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical disability or genetic information, military or veteran status, or any other protected classification, in accordance with federal, state, and/or local law. Should any applicant have concerns about discrimination in the hiring process, they should provide a detailed report of those concerns to for investigation.

Compensation and Benefits

A candidate’s pay within the range will depend on their work location, skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year.

How You’ll Grow

At HCLTech, we offer continuous opportunities for you to find your spark and grow with us. We want you to be happy and satisfied with your role and to really learn what type of work sparks your brilliance the best. Throughout your time with us, we offer transparent communication with senior-level employees, learning and career development programs at every level, and opportunities to experiment in different roles or even pivot industries. We believe that you should be in control of your career with unlimited opportunities to find the role that fits you best.

About Triple Crown

Triple Crown is a nationwide technology and engineering firm that connects top-tier talent with some of the most innovative companies in the world. Specializing in Hardware, Embedded, Software, and Mechanical engineering, we’re trusted by Fortune 500 companies and fast-growing startups to deliver highly skilled professionals.

With seven offices across the U.S. and a candidate-first approach, we move fast to meet the demands of today’s most complex projects. Our team is relationship-driven, results-focused, and passionate about helping engineers and clients thrive.

Recognized as one of the largest and fastest-growing staffing firms in the industry, we’re proud of our bold, high-energy culture built on strong values, real collaboration, and unlimited growth potential.

Account Manager

You will receive extensive hands-on training from our L&D team along with our top performers. During this period, you will learn the fundamentals of sales, staffing and customer service.

As an Account Manager at Triple Crown, you will:

• Build and manage a portfolio of qualified clients in the tech and engineering space
• Engage daily over the phone to attract and grow new business while also maintaining strong ongoing relationships with current client portfolio
• Identify and generate new job opportunities by understanding client needs and project goals
• Ensure a high level of client satisfaction through proactive communication and dependable service
• Drive revenue growth by expanding existing accounts and securing new business
• Conduct meetings with prospective clients to understand hiring cycles and establish trusted partnerships
• Prepare and present tailored proposals that align with client needs and showcase Triple Crown’s value

People Who Are Successful In This Role Are:

• Focused self-starters who pay high attention to detail and have a strong work ethic, positive attitude, and a commitment to exceed set expectations
• Able to quickly learn new technology
• Excellent communicators, both over the phone and in email—sense of humor a plus!
• Thrive in a fast-paced environment and work well under pressure

Things We Have to Offer:

• Great work/life balance
• Competitive compensation structure, base + uncapped commission
• Health, dental and vision benefits
• 401K option
• 3 weeks of PTO + all national holidays
• We are also closed Christmas – New Year’s Day and July 4th week- yes, all paid!
• Company outings and happy hours
• Opportunity for growth
• Annual company trip for Diamond Club, we’ve gone to Las Vegas, the Bahamas, Miami, Mexico, Cayman Islands, Cancun, and this year Cabo!

Does this sound like you? Apply today and take the first step toward a rewarding and fulfilling career!

Triple Crown Consulting provides equal employment opportunities to all employees and employment applicants without regard to considerations of race, color, religion or creed, gender, sex (including pregnancy), national origin or ancestry, ethnicity, citizenship status, genetic information, military or veteran status, age, and physical or mental disability, or any other classification protected by applicable local, state, or federal laws. Triple Crown Consulting does not tolerate discrimination in any aspect of employment, including, but not limited to, hiring, job assignment, compensation, promotion, benefits, training, discipline, and termination.

• We are a leader in our industry
• We offer long term career stability
• Opportunities for continued learning, development & advancement
• Excellent pay
• Great benefits
• Positive company culture
• Ability to make an immediate impact

• Control System Troubleshooting & Repair: Diagnose and repair PLC-based press control systems, hydraulic motion control circuits, and servo systems.
• Installation & Commissioning: Install, configure, and commission control systems for hydraulic and servo electric presses, ensuring proper integration of PLCs and peripherals
• Retrofits & Upgrades: Assist in modernizing hydraulic press controls, upgrading outdated PLCs, HMIs, motion controllers, and hydraulic servo systems for improved performance and automation.
• Field Service & Customer Support: Provide on-site and remote troubleshooting for hydraulic and servo electric press controls, minimizing downtime, and ensuring customer satisfaction.
• Programming & Debugging: Develop, modify, and troubleshoot PLC logic, HMI screens, motion control programs, and press automation sequences.
• Preventive Maintenance & Optimization: Conduct control system inspections and hydraulic system tuning to enhance system performance and reliability.
• Documentation & Reporting: Maintain service reports, control schematics, wiring diagrams, and software backups for customer and internal records.
• Training & Collaboration: Work closely with engineering, production, and service teams to provide training and guidance on press control systems.

• Bachelor’s degree in a technical field, most commonly Electrical or Mechanical Engineering
• 5-7 years’ experience in a manufacturing environment
• 7-10 years industry experience without a bachelor’s degree
• Self-starter who is adaptable to work independently and within a team environment
• Excellent communication skills and the ability to work in an interactive group environment are essential.

Kelly Science and Clinical FSP is currently seeking a Sr Clinical Research Specialist for a long-term engagement in Irvine, CA with one of our Global Medical Device clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

This Senior Clinical Research Specialist will be responsible for supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.

DUTIES & RESPONSIBILITIES*

Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate client, procedures and guidelines, this position:

• Serve as a Senior Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones.
• Oversight/execution of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures;
• May serve as the primary contact for clinical trial sites (e.g. site management);
• Contribute towards development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports,….), ensure registration on from study initiation through posting of results and support publications as needed;
• Management/oversight of ordering, tracking, and accountability of investigational products and trial materials;
• Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel;
• Oversee the development and execution of Investigator agreements and trial payments;
• Responsible for clinical data review to prepare data for statistical analyses and publications;
• If applicable, may perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;
• May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects;
• If applicable, as part of a clinical trial, may provide on-site procedural protocol compliance and data collection support to the center;
• Contribute to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated;
• Contribute to delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);
• Responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;
• Support project/study budget activities as assigned;
• Develop a strong understanding of the pipeline, product portfolio and business needs;
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;
• Perform other duties assigned as needed;
• Generally manages work with supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but required guidance for complex situations.

EXPERIENCE AND EDUCATION*

Education

• Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.

Experience

• BS with at least 2-4 years, MS with at least 3 years, PhD with at least 2 years of relevant experience preferred.
• Previous experience in clinical research or equivalent is required.
• Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).
• Clinical/medical background a plus.
• Medical device experience highly preferred
• Class III Medical Device experience (implantable) preferred

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*

Functional and Technical Competencies:

• Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations;
• Proven track record in supporting delivery of clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations;
• Good presentation and technical writing skills;
• Good written and oral communication skills;

Leadership Competencies:

• Ability to lead small study teams to deliver critical milestones, as may be assigned.
• Leadership required in alignment with J&J Leadership Imperatives:
• Connect - Develop collaborative relationships with key internal and external stakeholders.
• Shape - Make recommendations for and actively participate in departmental process improvement activities.
• Lead - Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations.
• Deliver - Strive to ensure all deliverables on allocated studies are met on time, within budget and in compliance to SOPs and regulations.

LOCATION & TRAVEL REQUIREMENTS

Primary location for this position is Irvine.

• Ability to travel approximately 20% depending on the phase of the program.

EXTERNAL INTERACTIONS

• Frequent (several times per month) interaction with physicians and research staff at centers selected for involvement in clinical research as well as those being evaluated.
• May have regular interaction with third party vendors supporting clinical studies as applicable per program.