Engineering Structures Impact Factor Jobs in Silverado California

• Leading the Naval network warfare missions in developing tactics and procedures to realize tactical, strategic and business advantages afloat and ashore
• Driving interoperability with joint, allied and coalition partners
• Building professional excellence through education, training and certification and milestone qualifications
• Optimizing organizational effectiveness through cutting-edge technologies, knowledge management techniques and a culture of innovation
• Helping to develop and deploy information systems, command and control and space systems
• Serving as a key part of the Information Dominance Corps in its mission to gain a deep understanding of the inner workings of adversaries
• Overseeing the work of Information Systems Technicians - Enlisted Sailors (no degree required) who serve as specialists in information technology

• Serving as part of Battle Group staffs on ships at sea
• Working in C4I/Space/Surveillance on shore tours
• Serving on major Navy and joint staffs
• Serving in command of key communication and surveillance facilities around the globe

• Pursuing opportunities at institutions such as Naval Postgraduate School (NPS) or Navy War College (NWC)
• Completing Joint Professional Military Education (JPME) at one of the various service colleges

Safety, Health & Environmental Manager

Anaheim, CA, US

The Safety, Health & Environmental Manager (SHE) will provide oversight, directions, and be accountable for the ongoing development and continuous improvement of the Safety, Health, and Environment (SHE) programs for dsm-firmenich manufacturing operations in Anaheim, CA. Additionally, will be responsible for the SHE management of the overall site including offices and laboratories. They will also serve as the site’s initial point of contact for safety and environmental related questions.

Your key responsibilities

• Responsible for supporting and providing process maintenance and continuous improvement for all safety programs of the Anaheim, CA location, which include hands on assistance, program implementation, training, and organization of monthly meetings and inspections.
• Ensure adherence to all management systems including, ISO 9001, ISO 14001 and ISO 45001, OSHA and FSSC 22000, with an understanding of dsm-firmenich’s SHE Policies and Procedures. Responsible that these policies and procedures are implemented throughout the organization and all related activities under the position’s jurisdiction. Leads site SHE-S audits and environmental programs to assure compliance and continuous improvement.
• Responsible for regulatory compliance related to hazardous materials management, hazardous waste management (both chemical and biological), wastewater, and DOT regulations (Local, State and Federal). Interfaces with regulatory agencies and authorities as appropriate.
• Records and tracks injury and safety related data to derive performance metrics for analysis of trends and reporting metrics to upper management. Shapes proposals on how to help foster positive trends while mitigating negative trends.
• Supports line management and promotes a culture of safety in manufacturing, office, and laboratory environments.
• Provides guidance and support which ensures compliance for the safe work permitting process (e.g., hot-work, lock-out tag-out try-out, work at height, ergonomics, hazardous material), including writing and issuing permits. Auditing all documents related to the permits.

We offer

• Unique career paths across health, nutrition and beauty - explore what drives you and get the support to make it happen
• A chance to impact millions of consumers every day – sustainability embedded in all we do
• A science led company, cutting edge research and creativity everywhere – from biotech breakthroughs to sustainability game-changers, you’ll work on what’s next
• Growth that keeps up with you – you join an industry leader that will develop your expertise and leadership
• A culture that lifts you up – with collaborative teams, shared wins, and people who cheer each other on.
• A community where your voice matters – it is essential to serve our customers well.

Your bring

• BS/BA/MS in Scientific or Engineering discipline; a degree in Safety, Safety Engineering, Industrial Hygiene or related discipline is preferred.
• 5+ years of SHE experiences making decisions which affect employee health & safety or facility compliance along with experience in managing laboratory operations.
• Must have demonstrated knowledge of all applicable California and federal EPA, OSHA, and DOT regulations and experience in auditing compliance thereto.
• Practical experience in health, safety and environmental areas including lockout-tagout-tryout, work at heights, lifting and hoisting, inspections and audits of the safety program, root cause analysis, health risk assessment, risk reduction training, hazard communication, industrial hygiene, etc.; proven track record of success establishing meaningful, interpersonal relationships through the ability to influence, with personnel at all levels.
• Must have ability to effectively communicate safety, health, and environmental processes and requirements, including experience with computer-based training systems, Microsoft Word (i.e. procedure documentation and formatting), Excel (i.e. creating workbooks, writing formulas with functions) and PowerPoint (i.e. creating slides for training and presentations).
• Preference for candidates holding active safety certification (CHMM, ASP, CSP). Must be able to support and facilitate 24/7 response to emergencies related to facility operations and safety/security events

The salary or hourly wage scale provided reflects the pay range dsm-firmenich expects to pay the successful candidate for the position. Individual pay offered will be based on the applicant’s job-related skills, experience, relevant education, or training, and primary work location. Salary $95,000-$150,000.

In addition to base salary, we also offer a comprehensive total rewards package, inclusive of annual incentive pay, a retirement savings plan, health care coverage, paid time off, recognition programs and a broad range of other benefits. All benefits and incentives are subject to eligibility requirements.

About dsm-firmenich

At dsm-firmenich, we don’t just meet expectations – we go beyond them.

Join our global team powered by science, creativity, and a shared purpose: to bring progress to life.

From elevating health to making fortified food and sustainable skincare, the impact of your work here will be felt by millions – every single day. Whether it’s fragrance that helps you focus, alternative meat that’s better for the planet, or reducing sugar without losing flavor, this is where you help shape the future of nutrition, health, and beauty for everyone, everywhere.

And while you’re making a difference, we’ll make sure you’re growing too. With learning that never stops, a culture that lifts you up and the freedom to move across businesses, teams, and borders. Your voice matters here. And your ideas? They’re essential to our future.

Because real progress only happens when we go beyond, together.

Inclusion, belonging and equal opportunity statement

At dsm-firmenich, we believe being a force for good starts with the way we treat each other. When people feel supported, included, and free to be themselves, they do their best work – and that’s exactly the kind of culture we’re building. A place where opportunity is truly equal, authenticity is celebrated, and everyone has the chance to grow, contribute, and feel they belong.

We’re proud to be an equal opportunity employer, and we’re serious about making our hiring process as fair and inclusive as possible. From inclusive language and diverse interview panels to thoughtful sourcing, we’re committed to reflecting the world we serve.

We welcome candidates from all backgrounds — no matter your gender, ethnicity, sexual orientation, or anything else that makes you, you.

And if you have a disability or need any support through the application process, we’re here to help – just let us know what you need, and we’ll do everything we can to make it work.

Agency statement

We’re managing this search directly at dsm-firmenich. If you’re applying as an individual, we’d love to hear from you. We’re not accepting agency submissions or proposal

American Equipment Holdings is an organization of leading overhead crane and hoist fabricators, distributors and field service providers, including American Equipment, Allied Crane, Eastern Crane & Hoist, Facilities Engineering, Kistler Crane & Hoist, Pacific Crane & Hoist, Patriot Crane & Hoist, Shannahan Crane & Hoist, and Washington Crane & Hoist. The consolidated entity is one of the largest independently owned overhead crane and hoist solutions providers in the country, serving over 4,000 customers nationwide.

Together, American Equipment Holdings companies provide comprehensive solutions for everything related to customers’ overhead crane and hoist needs, including OSHA mandated inspections, preventative maintenance and repair field services, parts, engineering, ISO certified fabrication, new and replacement equipment, automated systems, system modernizations and training.

We are looking for a Field Maintenance Install Technician (Experienced Ironworker) in our Anaheim location.

Essential Duties and Responsibilities:

• Work as part of team to install equipment. With a focus on safety and customer service.
• Accurately and neatly document work performed using a combination of electronic forms, software applications, and traditional handwritten reports where required.
• Maintain a clean and safe work environment.
• Travel may be required to install sites.

Required Skills/Abilities

• Iron work/steel erection experience.
• Aptitude for either electrical or mechanical environments as well as familiarity with mechanical and electrical equipment
• Comfort with working at heights
• Welding experience- Wire Feed (MIG), Stick (SMAW)
• Hands-on electro-mechanical maintenance or equivalent military experience a plus
• Competence in equipment operation. Reach forklifts, scissor lifts.
• Ability to read blueprints and schematics
• Ability to work well in a team environment.
• Strong communication skills
• Proven commitment to safety
• Passion for doing things right the first time.
• Industry certifications including equipment operator, Welding, Rigging will be a plus.
• Willingness to work overtime is required
• Possession of a valid driver’s license with good driving record
• Must pass drug-screen and background check

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

American Equipment Holdings represents the industry’s leading manufacturers such as Detroit Hoist, Columbus McKinnon, ACCO, R&M, Demag, Gorbel, Spanco, IMS, Harrington, Conductix, Magnetek & PE, among others and customers rely on its design, engineering, fabrication and installation capabilities to meet their unique application needs. American Equipment Holdings serves local, regional and national customers across a variety of end markets, including light & heavy industrial, automotive, mining, public utilities, military, aerospace & defense and energy, among others. For more information, visit of right to lawfully work in the United States required.

We are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

Compensation details: 24-32 Hourly Wage

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Role Summary/Purpose

The Production Supervisor at PCX Aerosystems Santa Ana, CA will lead daily operations in one of several departments at the plant to ensure reliability and consistency on the production line. Assignments may include time in the machine shop, assembly, test, overhaul and fuel tank departments. This role will lead a team of hourly production employees to meet orProexceed production, safety, quality goals and delivery goals while maintaining positive employee relations.

Essential Responsibilities

• 
  
• Oversight and management of front-line hourly manufacturing employees
  
• Develop operational plans for assigned areas/departments of responsibility including, but not limited to: asset utilization, manufacturing loss improvements, delivery, budgets and effective scheduling of manpower / resources
  
• Act as a focal point and monitor assigned areas to ensure hardware and subassemblies' delivery dates meet production needs
  
• Coordinate the efforts of cross-functional groups and across shifts to resolve bottlenecks
  
• Assure timely shipments to all customers
  
• Drive process/product improvement programs in areas of responsibility
  
• Enforce company policies
  
• Lead cell/group to achieving goals and improvement in quality, delivery and cost reduction
  
• Ensure communication of key business/customer issues to employees
  
• Provide total cell/group leadership to continuously improve manufacturing, test, assembly and process for all assigned products/processes/areas as assigned
  
• Advocate six sigma processes to all aspects of cell/group
  
• Provide ongoing support in the scheduling of resources, technical leadership and facilitating the production process and flow of hardware to meet customer requirements
  
• Proactively support and participate in plant wide activities and initiatives
  

Works with business leadership at all levels

Delivers products as part of a team.

Qualifications/Requirements

* Bachelor's degree from an accredited university or college (or a high school diploma/GED with at least 5 years of experience in Manufacturing)

* Minimum 3 additional years of supervisory experience in operations/industrial environments

* Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.

Desired Characteristics

* Bachelor's degree in Engineering preferred

* Ability to work non-traditional hours including weekends as needed

* Strong oral and written communication skills.

* Strong interpersonal and leadership skills.

* Ability to influence others and lead small teams.

* Lead and coordinate multiple initiatives of moderate scope and impact simultaneously

* Effective problem solving skills.

* Ability to effectively work across all functions (i.e., HR, finance, sourcing, production, materials, shipping/receiving, sales, contracts, EHS, etc.) within a matrix organization to achieve organizational goals/objectives

* Prior experience leading production teams within a manufacturing environment

* Prior experience in Machining and/or Fabrication/Assembly

* Experience as manufacturing process leader preferred

* Aerospace industry experience preferred

* Six Sigma / Green belt certified preferred

* Familiarity with Lean Manufacturing, working with VSM, Visual Management and DMAIC principals

* Ability to complete manpower planning and analysis including productivity, efficiency and overtime management

LANGUAGE SKILLS

Ability to effectively communicate with peers and supervisors and provide technical feedback as

required. Ability to read and comprehend simple instructions, company communications, and

memos. Ability to write reports and simple correspondence. Ability to effectively present information

in one-on-one and small group situations to customers, clients, and other employees of the

organization.

MATHEMATICAL SKILLS

Ability to apply concepts of basic math techniques.

COMPUTER SKILLS

To perform this job successfully, an individual must be proficient in basic computer skills.

REASONING ABILITY

Ability to define and solve practical problems. Ability to interpret a variety of technical instructions in

mathematical, diagram, written or verbal format. Ability to deal with problems involving several

abstract and concrete variables in standardized situations. Ability to apply common sense

understanding to carry out instructions furnished in written, oral, or diagram form.

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 accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee must be able to stand at least 6 to 8 hours a day. Must be able to work with their hands, arms and be extremely accurate. Must be able to walk, sit, stoop, kneel, crouch, or crawl on a regular basis. Must be able to lift and/or move up to 10 pounds on a frequent basis. Must be able to lift and/or move up to 25 pounds on a regular basis. Specific vision abilities required by this job include close & color vision

WORK ENVIRONMENT
While performing the duties of this job, the employee is regularly exposed to moving high speed machinery and mechanical parts. The employee is occasionally exposed to wet and/or humid conditions. outside weather conditions, machine oils, metal fillings, acetone, paints, solvents, grease, cutting fluids, fumes or airborne particles, toxic or caustic chemicals, and risk of electrical shock or vibration. The noise level in the work environment is usually loud.

Integral Aerospace, Inc dba PCX Aerosystems - Santa Ana is an equal opportunity/affirmative action employer. We consider applicants without regard to race, color, religion, creed, gender, national origin, age, sex, sexual orientation, disability, genetic information, marital or veteran status, or any other category protected by federal, state or local law.

This position is currently accepting applications.

Apply Now

A respected employment defense law firm is seeking a talented Employment Defense Attorney to join its growing team. This is an excellent opportunity to work with a group of highly experienced attorneys who focus exclusively on representing employers in complex employment law matters.

The firm represents major national and regional employers in high-stakes employment litigation and counseling matters. Attorneys at the firm have backgrounds from top law schools and nationally recognized law firms, and the practice is known for its strong litigation results and strategic client advocacy.

This role offers the opportunity to work on sophisticated employment litigation matters while enjoying a collaborative environment and flexible work structure.

Responsibilities:

• Defend employers in employment-related litigation
• Handle cases involving discrimination, harassment, retaliation, wage & hour, and wrongful termination
• Manage single-plaintiff and complex employment litigation matters
• Conduct legal research, drafting, and motion practice
• Participate in depositions, hearings, mediations, and trial preparation
• Provide counseling to employers on compliance with state and federal employment laws

Qualifications:

• JD from an accredited law school
• Active California Bar license
• Experience in employment defense litigation preferred

Salary and Other Compensation:

The annual salary for this position is between $180,000 – $250,000. Factors which may affect pay within this range may include geography/market, skills, education, experience and other qualifications of the successful candidate.

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements:

• medical insurance
• dental insurance
• vision insurance
• 401(k) match + retirement plan
• 3 weeks PTO
• performance-based bonus

A leading defense firm is looking for an Insurance Defense Attorney to handle construction defect, product liability, premises liability, and bodily injury matters. This is a chance to take on complex, high-value cases while working with a collaborative, top-tier team.

What You’ll Do

• Lead a diverse caseload from start to finish.
• Handle depositions, mediations, negotiations, and court appearances.
• Provide strategic counsel and partner closely with clients.
• Target 1900 billable hours annually with strong bonus incentives.

What We’re Looking For

• JD + active state bar admission.
• 3+ years of insurance defense experience.
• Experience in construction defect, product liability, or premises liability.
• Strong litigation, writing, and negotiation skills.

Why Join

• The annual salary for this position is between $160,000 - $210,000. Factors which may affect pay within this range may include geography/market, skills, education, experience and other qualifications of the successful candidate.
• Bonus structure that rewards billables and client development.
• Comprehensive benefits.
• A firm culture that combines big-firm resources with a tight-knit team feel.
• Real opportunities to grow your practice and your career.

So, if you are a talented Insurance Defense Attorney who has their CA bar, and is ready to take the next step in their career, apply today!

Monument is a leading right-of-way consulting firm that provides property acquisition, appraisal, relocation, and related real estate services for public infrastructure projects. Our clients include Federal, State, and local agencies, utility providers, and engineering firms, among others. We pride ourselves on our unique, fully remote workplace culture, where innovation and growth are fostered in a supportive and inclusive environment.

Position: Proposal Coordinator

Location: Remote | Full-Time

Pay: $75k-$90k

Position Description

Monument is seeking a dedicated and talented Proposal Coordinator with exceptional writing, editing and organizational skills to support our fast-paced marketing and business development team. We respond to a high volume of Requests for Proposals (RFPs) that require the development and submission of customized, pursuit-specific proposals that strategically spotlight Monument’s value while meeting the required parameters of each request. The primary responsibility of this role is the end-to-end management of the proposal lifecycle and production process, which includes thoughtful, non-technical, writing and content development, as well as administrative support, including scheduling and management of key milestones and deadlines. Additional department duties include the creation of customized marketing and promotional materials to support all company business lines.

Detailed Requirements and Responsibilities:

·      Collaborate with technical writers, project managers and other team members to develop high-quality, compliant and engaging proposals.

·      Write and edit proposal content with a focus on relevancy, accuracy and persuasiveness.

·      Customize staff resumes, project experience write-ups, executive summaries and management plans, etc.

·      Organize, store and archive proposal components to quickly compile and provide upon request.

·      Select and customize appropriate writing templates to create proposal drafts.

·      Research and collect information relevant to each pursuit for use in proposals.

·      Review technical input and translate complex concepts into client-ready narratives.

·      Analyze RFPs, SOQs, and advertisements; prepare compliance and requirement checklists, outlines, and proposal schedules.

·      Compliance and Quality Assurance – conduct thorough reviews of RFP requirements to ensure all elements of submission meet requestor specifications, internal guidelines and legal standards.

·      Finalize and submit proposals per RFP requirements.

·      As needed, coordinate for formatting, binding, printing and mailing of physical submissions.

·      Schedule, facilitate, and document proposal kick-off and color review milestones.

·      Compile and distribute meeting notes, action items, and reviewer feedback.

·      Coordinate proposal resources, including technical team input, subconsultant content, and supporting documentation.

·      Develop and manage proposal production schedules.

·      Ensure incorporation of review feedback and adherence to internal quality standards.

·      Support interview teams as needed, under senior management oversight.

Qualifications

·      Architecture or Engineering industry-based proposal writing experience is strongly preferred.

·      Strong organizational skills with the ability to manage multiple deadlines.

·      Excellent written, verbal, and interpersonal communication skills.

·      Detail-oriented with a commitment to accuracy and quality.

·      Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and Adobe Acrobat Pro.

Education and Experience

·      Bachelor’s degree in Communications, Marketing, English, Business, or related field preferred.

·      3–5 years of proposal writing or coordination experience, preferably in professional services, engineering, or construction industries.

How to Apply:

Learn more about our company and explore how you can be part of our shared vision at . Submit your resume and a detailed cover letter through our Careers page to take the first step toward joining the Monument team.

MONUMENT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

Proposal Estimator

Location: On-site role in Anaheim, CA

Ignite growth with a firm that is reshaping how architecture and engineering projects are won. Our confidential client is expanding its national design footprint and needs a decisive Proposal Estimator to translate vision into winning bids. Reporting directly to executive leadership, you will own the estimating life cycle—balancing precision, speed, and profitability—while working shoulder-to-shoulder with high-performing sales, marketing, and technical teams. If you thrive on tackling complex project scopes and turning them into clear, competitive proposals, this is your next career springboard.

Key Responsibilities

• Estimate with confidence – quantify level of effort (hours, resources, third-party costs) for multi-disciplinary A/E projects.
• Shape bid strategy – align pricing models with margin targets, market dynamics, and client requirements to maximize win probability.
• Build repeatable tools – develop templates, macros, and dashboards that cut proposal cycle time and improve data accuracy.
• Bridge the business – translate design inputs into commercial terms and ensure sales commitments are operationally feasible.
• Leverage data – capture win/loss analytics in CRM/ERP systems and refine assumptions using historical performance metrics.

Qualifications & Skills

• AEC estimating expertise – proven success creating proposals or LOE estimates for architecture, engineering, or related professional-services projects.
• Systems savvy – advanced Excel or comparable estimating software; experience with Deltek, Salesforce, or similar platforms is advantageous.
• Clear communicator – exceptional written/verbal skills and the ability to convey technical detail to non-technical stakeholders.
• Process mindset – history of automating workflows and standardizing documents to drive scalability.
• Bachelor’s degree in engineering, construction management, business, or equivalent experience.
• Authorization to work in the United States.

Why Apply?

• Strategic seat at the table – partner directly with senior leadership on high-visibility growth initiatives.
• Career runway – join a nationwide platform committed to professional development, mentorship, and long-term advancement.
• Robust benefits – comprehensive healthcare, retirement match, generous PTO, and employer-supported relocation if needed.

About Blue Signal:

Blue Signal is an award-winning, executive search firm specializing in various specialties. Our recruiters have a proven track record of placing top-tier talent across industry verticals, with deep expertise in numerous professional services. Learn more at /46Gs4yS

We are a Southern California-based consulting firm specializing in land use planning, entitlements, and CEQA compliance for complex real estate and infrastructure projects. Our strategic, solution-oriented approach helps clients navigate regulatory processes from due diligence through approvals. With a strong track record and deep relationships with agencies, we deliver certainty and results across both public and private sector developments.

We’re seeking a Land Use Project Manager who is passionate, strategic, and ready to lead high‐impact real estate entitlement and post‐entitlement efforts through California’s rigorous environmental review process (CEQA). You’ll champion projects from feasibility through construction, ensuring timely approvals while safeguarding environmental integrity.

Salary and Other Compensation:

• The annual salary for this position is between $120K-$150K + bonus. Factors which may affect pay within this range may include geography/market, skills, education, experience and other qualifications of the successful candidate.
• Full Benefits Package:
• Comprehensive Health, Dental & Vision Plans
• 401(k) with Company Match
• Paid Time Off & Holiday Schedule
• Professional Development & Certification Support
• Flexible/Hybrid Work Options

Key Responsibilities and Requirements

• Drive entitlement strategy: coordinate with planners, architects, and legal counsel.
• Prepare and manage applications for zoning, conditional use permits, variances, and general plan amendments.
• Lead coordination meetings and ensure all conditions of approval are met.
• Strong CEQA Expertise:
• Direct preparation and review of Initial Studies, Environmental Impact Reports (EIRs), Negative Declarations, and Mitigated Negative Declarations.
• Collaborate with environmental consultants, community stakeholders, and agency staff to mitigate project impacts and secure CEQA clearance.
• Stakeholder Engagement:
• Cultivate strong relationships with city/county planning departments, public works, and community groups.
• Present project updates at public hearings and planning commission meetings.
• Team & Budget Management:
• Mentor junior planners, delegate tasks, and manage budgets and schedules to meet project goals.
• 5+ years in land use planning, entitlement, and post‐entitlement project management—preferably in California.
• Technical Proficiency: Deep knowledge of CEQA regulations and local planning ordinances.

What the Firm Offers

Salary and Other Compensation:

The annual salary for this position is between $120,000 and $150,000, based on experience. Factors which may affect pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

*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.