Buffalo Grove, Illinois, United States · On-site
$210k–$330k/yr
Overview Find a Better Way... ...to use your skills and experience. This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using …
Skills: Clinical Strategy, IVD Product Development, FDA Regulatory Submissions, GCP, GLP
Buffalo Grove, Illinois, United States · On-site
Overview: The Custodian is responsible for maintaining a clean, safe, and organized facility environment that supports production, warehouse, and office operations. This position performs routine cleaning, sanitation, wa…
Skills: Sanitization, Waste Removal, Floor Maintenance, Facility Upkeep, Safety Compliance
Buffalo Grove, Illinois, United States · On-site
$168k–$264k/yr
Overview Find a Better Way... ...to use your skills and experience. This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using …
Skills: Clinical Strategy, IVD Product Development, FDA Regulatory Submissions, GCP, GLP
Buffalo Grove, Illinois, United States · On-site
$26/hr–$36/hr
Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference …
Skills: Process Auditing, First Article Inspection, Root Cause Investigation, Statistical Quality Control, Engineering Drawing Interpretation
Buffalo Grove, Illinois, United States · On-site
Overview: At Zebra, we are a community of innovators who come together to create new ways of working. United by curiosity and a culture of caring, we develop smart solutions that anticipate our customer’s and partner’s n…
Skills: Shipping And Receiving, Inventory Management, Forklift Operation, Pallet Jack Operation, Order Picking And Packing
Buffalo Grove, Illinois, United States · On-site
Overview: At Zebra, we are a community of innovators who come together to create new ways of working. United by curiosity and a culture of caring, we develop smart solutions that anticipate our customer’s and partner’s n…
Skills: Shipping And Receiving, Inventory Management, Forklift Operation, Pallet Jack Operation, Order Picking And Packing
Buffalo Grove, Illinois, United States · On-site
Overview Wieland - Creating Value for Generations! Wieland is a global leader in copper and copper alloy manufacturing, processing, and distribution. We provide a large product and service portfolio including power, auto…
Skills: CNC Machining, Quality Inspection, Troubleshooting, Overhead Crane Operation, Measurement Math
Buffalo Grove, Illinois, United States · On-site
$89k–$123k/yr
Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference …
Skills: Project Management, Quality Remediation, CAPA, ISO 13485, FDA QSR
Buffalo Grove, Illinois, United States · On-site
Overview Wieland - Creating Value for Generations! Wieland is a global leader in copper and copper alloy manufacturing, processing, and distribution. We provide a large product and service portfolio including power, auto…
Skills: CNC Machining, Quality Inspection, Overhead Crane Operation, Troubleshooting, Measurement Math
Buffalo Grove, Illinois, United States · On-site
$26/hr–$35/hr
Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference …
Skills: Injection Molding, Mold Setup, Troubleshooting, Quality Assurance, Process Optimization
Buffalo Grove, Illinois, United States · On-site
$100k–$137k/yr
Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference …
Skills: Manufacturing Systems, Root Cause Analysis, Troubleshooting, Engineering Change Orders, Process Control
Buffalo Grove, Illinois, United States · On-site
$34/hr–$47/hr
Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference …
Skills: CNC Machining, Jig Grinding, Machine Set-up, Blueprint Reading, Precision Measurement
Buffalo Grove, Illinois, United States · On-site
$34/hr–$47/hr
Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference …
Skills: PLC Troubleshooting, HMI Programming, Motion Control, VFDs, Servo Motors
Buffalo Grove, Illinois, United States · On-site
$26/hr–$36/hr
Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference …
Skills: Tooling Fabrication, Precision Machining, Blueprint Reading, Mechanical Design, Shop Mathematics
Buffalo Grove, Illinois, United States · On-site
$21/hr–$29/hr
Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference …
Skills: Communication Excellence, Emotional Intelligence, Adaptability, Cultural Sensitivity, Problem-Solving
Buffalo Grove, Illinois, United States · On-site
$72k–$98k/yr
Job Description Who will you be working with? You'll be joining Wabtec Bus Solutions, a team driving innovation in Transit Bus & Rail systems, including passenger door systems, wheelchair lifts & ramps, e-Bus charging sy…
Skills: Electrical Design, PCB Design, Analog/Digital Circuits, Embedded Systems, Microcontroller-based Designs
Buffalo Grove, Illinois, United States · On-site
$79k–$113k/yr
Job Description As a Quality Engineer IV, you’ll serve as a senior technical resource for quality engineering, quality systems, customer quality, and manufacturing process improvement. You’ll lead high-impact initiatives…
Skills: Quality Engineering, 8D, DMAIC, APQP/PPAP, FMEA/PFMEA
Buffalo Grove, Illinois, United States · On-site
$21/hr–$29/hr
Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference …
Skills: Assembly Process Improvement, Machine Troubleshooting, Process Specification Evaluation, ISO Compliance, Equipment Calibration
Buffalo Grove, Illinois, United States · On-site
$22/hr–$28/hr
Job Description Responsibilities: Support and maintain all policies of the company including but not limited to ISO Standards, Health and Safety. Requirements, Continuous Improvement, GMP and standard work procedures. Ma…
Skills: Injection Molding, TPM, 5S Standards, SAP, Lean Manufacturing
Buffalo Grove, Illinois, United States · On-site
$75k–$104k/yr
Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference …
Skills: Production Management, People Management, Process Improvement, Operational Troubleshooting, Budget Planning
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The Senior Director is responsible for developing and executing the clinical strategy for new and modified IVD products, including preclinical and clinical evaluation plans. They will also oversee the operations of the Sysmex RACA Laboratory and serve as the Principal Investigator for IRB-approved studies.
Requires a Master's degree (PhD desired) and at least 15 years of clinical research experience, with 8 years in a leadership role. Candidates must have in-depth knowledge of GCP, GLP, and FDA regulations specifically related to IVD products.
This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using state-of-the-art technology, and improve lives with your innovative ideas and ambitious dreams. Find a better way: the Sysmex Way.
Headquartered in Kobe, Japan, Sysmex is located in Lincolnshire, Illinois. Renowned worldwide for the very finest in quality, innovative diagnostic equipment and information-management systems, we apply science to enhance the quality of life on a global scale. Our agile, resourceful team is committed to realizing critical breakthroughs in laboratory diagnostics, information technology, workflow analysis and life sciences for the clinical laboratory.
We currently have a great opportunity available for a Senior Director, Clinical Affairs. The Senior Director, Clinical Affairs will be responsible for developing, coordinating, and executing the clinical strategy for new and modified Sysmex IVD products. This position will be responsible for understanding the operating principles of the devices required, to develop preclinical and clinical evaluation plans including study protocols; determine study documentation requirements; and generate final reports and sections of FDA applications. The position will also be responsible for ensuring the operations of the Sysmex clinical laboratory, including functioning as the Principal Investigator for IRB-approved studies conducted in the RACA Laboratory. The Senior Director will also be responsible for maintaining relationships with outside institutions required to conduct the evaluations.
1. Direct and comply with all policies, established procedures, and regulations related to the studies. Maintain professional, product and market expertise via independent reading, networking and training. 2. Develop and execute clinical strategy for new/modified Sysmex IVD products including the development of preclinical and clinical evaluation plans in compliance with FDA and CLSI guidelines, GCP requirements, and recent FDA submissions for similar products. Function as a Subject Matter Expert where appropriate. Integrate clinical strategy with colleagues at S-Corp and other Sysmex Affiliates.3. Execute evaluations as above in alignment with business goals and objectives. Responsible for establishing, managing, and achieving project milestones with internal staff, other departments, and all study investigators and research coordinators.4. Ensure that associates are accountable for timely development of clinical trial documentation including instructions for use, case report forms (CRFs), CRF guidelines, informed consent, monitoring plans and reports, assisting with study protocol development and other necessary clinical/regulatory documentation. Mentor and support staff to achieve success and excellence in these areas.5. Oversee the progress of projects and assures adherence to intended timelines including enrollment, clinical supplies, and data management/delivery. Identify issues that may impact the overall project plan and initiate contingency plans, communicate with leadership, as appropriate.6. Direct the operations of the Sysmex RACA Laboratory in close alignment with the Laboratory Manager and function as the Principal Investigator for IRB-approved studies.7. Establish and maintain relationships with outside institutions required to conduct the appropriate evaluations including recruiting investigational sites, negotiating and maintaining budgets and contracts. 8. Contribute to clinical sections of regulatory submissions 9. Generate and author final reports appropriate to support regulatory filings.10. Other duties as required.
Percentage of Travel: Up to 35% of time
Physical Risk: Regular exposure to risk that may require alertness, but with minimal precautions.
Physical Demands: Light physical effort. Routine handling of objects up to 20 pounds; prolonged (at least 50% of time) sitting, standing, keyboard or CRT work. May require periods of moderate discomfort due to noise, dust, lighting and/or other conditions.
Master’s degree required (Medical/Science background highly desired), PhD degree desired. A minimum of 15+ years of clinical research experience required with minimum of 8 years’ experience leading clinical projects, including experience in the Armed Forces.
Experience in all aspects of preclinical and clinical study evaluations.
Technical laboratory instrument expertise/experience.
In depth knowledge of regulations and industry standards affecting preclinical and clinical studies of IVD products, including GCP & GLP.
Technical expert in the various aspects of the clinical evaluation process.
History of significant contribution to the success of planning and executing clinical strategies in support of product clearance.
Knowledge of regulations and standards affecting clinical and preclinical studies of Sysmex products.
English
Excellent general IT skills i.e. Microsoft Office/Outlook, Adobe etc. and basic statistics.Laboratory &/or LIS computer skills would be a plus.
Ability to follow guidelines and effectively communicate scientific data in a structured manner. Understands and interprets scientific data related to regulatory requirements and strategy and provides knowledge and expertise to guide others
Strong interpersonal skills, ability to interface effectively with all levels of staff and management, both internally and externally.
Excellent organizational skills and attention to detail.
Ability to manage multiple priorities.
The salary range for this role is $210,000 – 330,000. Within this range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. The total compensation package for this position also includes a choice of health care plan (medical, vision, and dental insurance), an annual incentive bonus, paid time off, parental leave, bereavement leave and a 401(K) for all eligible employees.
This job requires satisfaction of the credentialing requirements of Sysmex’s customers, including hospitals and other healthcare facilities, which generally includes proof of current vaccinations for measles, mumps, rubella, varicella (chicken pox), and COVID-19.
Sysmex is proud to be an EEO/Affirmative Action employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, age, sex, sexual orientation, gender identity or expression, color, religion, national origin, genetics, disability status, protected veteran status or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
Together for a better healthcare journey
Sysmex Corporation is a global leader in in vitro diagnostics. Since its foundation in 1968, Sysmex has focused on diagnostics as the core of its business, and today, it supports the health of people in over 190 countries and regions worldwide. Sysmex continues to innovate in diagnostics, and to collaboratively create unique values in the areas of personalized medicine and novel treatments, under its long-term vision of "Together for a better healthcare journey." Through its unique technology, solutions, and co-creation with various partners, Sysmex delivers new value and addresses the universal desire of people to live longer and healthier lives. Read our Social Media Policy here: https://www.sysmex.co.jp/en/policy.html
Offices: 1-5-1, Wakinohama-Kaigandori, Chuo-ku, Kobe, Hyogo 651-0073 , JP · 4丁目4番地の4, 高塚台, 神戸市西区, 兵庫県 651-2271, JP · 1丁目3番地の2, 室谷, 神戸市西区, 兵庫県 651-2241, JP
There are currently 110 open manufacturing positions in Buffalo Grove, IL listed on Clera. New openings are added daily as companies post roles.
Companies currently hiring include Flex, Westinghouse Air Brake Technologies Corporation, NEMERA, Wieland Group, Zebra Technologies, among others. Browse the listings above to see every active employer.
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