What's it like to work at Circadiance
Circadiance is always looking for talented people. If you are a motivated individual who takes your profession seriously and are looking for a career that will empower you to reach your highest potential, then Circadiance may be the company for you. We offer a fast paced, high performance environment where self-starters are given the opportunity to express their creativity.
We offer a competitive salary and benefits package in an exciting quickly-growing company.
Circadiance embraces diversity and is an equal opportunity employer.
Please submit your résumé via e-mail: careers@circadiance.com
Current job openings at Circadiance:
Assembler
Function:
Experienced, talented, and motivated individual to assume responsibility for assembling production devices, as well as a number of additional related production activities.
Education:
- Minimum education requirement is a High School diploma.
Experience:
- Minimum 5 years experience in a medical device assembly environment
- General record keeping skills, basic math skills, and excellent communication skills: both verbal and written.
- Basic computer competence is required. Experience using Microsoft Office is desirable.
- Familiarity with FDA and ISO medical device regulations as applied to production of product
Job Duties:
- Performs assembly, test, and packaging
- Ensure that all production equipment remains within calibration and in serviceable condition.
- Responsible for receiving and inspection of incoming components
- Responsible for shipment of product
- Order consumables as necessary to support production activities.
- Monitor inventory levels and, in accordance with the current sales forecast, and in consultation with senior management, ensure that adequate components and raw material are on order or available.
- Identify and communicate innovative ideas related to improving the Manufacturing processes, documentation, workflow, equipment, methods, etc.
- Monitor, record and report any unusual problems.
- Reads work orders, follows production drawings and sample assemblies, or receives verbal instructions regarding duties to be performed.
- Performs online go/no-go testing and inspection to ensure parts and assemblies meet production specifications and standards
- Sets up station with the correct documents and components per assembly drawing
- Assist in performing repair work
- Communicates any process problems with peers, leads, supervisors and/or engineers
- Perform preventative maintenance on production line machinery
To apply for this position please submit your résumé via e-mail: careers@circadiance.com
» return to the top of this page
Clinical Coordinator
Function:
Responsible for planning, conducting, analyzing results and writing reports for all clinical testing including: animal trials, brain dead human trials, terminal wean patient trials, compassionate use trials, safety trials and efficacy trials.
Education requirements:
A degree in a clinical field required, nursing or equivalent.
Experience:
- At least 10 years relevant experience.
- Experience conducting clinical trials a must.
Job Duties:
- Plan clinical trials to meet company objectives.
- Recruit principle investigators. Negotiate Investigator agreements.
- Write clinical trial protocols.
- Train investigators in the clinical protocol including insertion, patient management, data collection and reporting.
- Manage clinical sites. Serve as principal liaison between project team members, investigational sites, and the Principle Investigator.
- Ensure the clinical data forms are properly completed and verify clinical data against source documentation. Responsible for resolution of data queries.
- Prepare data summary for regulatory documentation.
- Responsible for financial management of clinical trials.
- Conduct internal clinical training
- Provide clinical support to Customer Service
- Establish a Medical Advisory Board
To apply for this position please submit your résumé via e-mail: careers@circadiance.com
» return to the top of this page
Customer Service Representative
Function:
The Customer Service Representative is the primary contact between the Customers and the Organization. This person must possess the ability to successfully convey the Company’s emphasis on quality service to the customer, whether that Customer is a CPAP user, Dealer, Sleep Lab or Distributor. The Customer Service Representative will create the customer’s first impression of the company.
Educational requirements:
BS/BA degree preferred
Experience:
Prefer experience in a Sleep Lab or Home Care Company.
Job Duties:
- Take Customer Calls
- Enter Customer Orders and complete the Order Processing.
- New Account Set-up
- Order Confirmation
- Respond to customer technical problems following company procedures
- Lead Management following company procedure
- Communicate with Field Sales personnel (including Dealers and Sales Reps) regarding special programs affecting the Customers
- Issue periodic status trend reports
- Support Marketing Staff to develop effective marketing programs.
- Conduct Customer Surveys by phone, in writing and through internet enabled survey tools
To apply for this position please submit your résumé via e-mail: careers@circadiance.com
» return to the top of this page
Director of Quality Assurance & Regulatory Affairs
Function:
Responsible for product approval of medical devices for distribution worldwide. Responsible for regulatory compliance of the quality system. Responsible for QSR and ISO system development, implementation and compliance.
Education requirements:
- A degree in engineering or life science
- Advanced degree in QA systems a plus
Experience:
- At least 10 years relevant experience.
Job Duties:
- Monitor and develop the company quality system.
- Write regulatory submissions for the medical devices developed by the company.
- Provide regulatory input to engineers during the development process.
- Review and approve key events during the development of new products and product changes including quality plans, product and process validation, and pilot runs.
- Write and review procedures for Regulatory Affairs and other functional elements of the quality system.
- Serve as the Management Representative for the Quality System.
- Supervise the execution of all clinical trials.
- Certify that every production lot is manufactured according to its device master record.
- Review and approve change orders to ensure that they meet regulatory requirements.
- Escort regulatory and certification agency representative if they come to our site.
To apply for this position please submit your résumé via e-mail: careers@circadiance.com
» return to the top of this page
Documentation Specialist
Function:
The Documentation Specialist manages the flow of change orders, creates and modifies documents, controls of issues part and document numbers and manages the document files. The Specialist will be called upon to participate in special projects affecting the Documentation Department.
Education requirements:
Minimum requirements include post secondary education in engineering technology, engineering drawing, manufacturing materials and processes, technical writing and non-programming computer applications.
Experience:
- 2 years of experience working with bills of material, production, quality control, and engineering documentation is required.
- Prior experience as a Documentation Specialist, or knowledge of document control systems is required. Knowledge of FDA and ISO regulations in a medical device company required.
- Formal training in computer system use is required.
- Must be able to structure bills of material for use in an MRP system.
Job Duties:
- Manage the Documentation File system. Ensure that the file system integrity is maintained whether on paper or electronic.
- Maintains contents of the device master record keeping it current, complete and consistent.
- Distribute reference documents to the appropriate parties.
- Coordinate the Change Order Process.
- Design forms for use in the documentation system.
- Manage the engineering library
- Train associates in the use of the documentation and change order system.
- Assure department reports are distributed in a timely and accurate manner.
- Manage the issue of document numbers for new documents following procedures
To apply for this position please submit your résumé via e-mail: careers@circadiance.com
» return to the top of this page
Engineering Technician
Function:
Assist Project Engineer with the testing of prototypes
Education requirements:
Degree in Engineering Technology
Experience:
Minimum of 2 years’ relevant experience.
Job Duties:
- Do testing according to approved test plans.
- Write test reports.
- Develop work instructions (like drawings & procedures) that demonstrate how tests were conducted so that production operators could later conduct a test if required.
- Assemble prototype devices.
To apply for this position please submit your résumé via e-mail: careers@circadiance.com
» return to the top of this page
Manufacturing Engineer
Function:
The Manufacturing Engineer is responsible for ensuring technical production problems do not negatively impact product quality or shipment schedules. The Manufacturing Engineer works with Product Development and primary sub-contractors to support the introduction of new products into production.
Education requirements:
BS in Engineering
Experience:
Over five years experience in production line layout, work methods and production troubleshooting in a medical device manufacturing environment.
Job Duties:
- Troubleshoot component, production and field related quality problems, design fixes and work with design team and factory to implement the fixes.
- Work with Design Engineering team to provide the manufacturing portion of the new product development process (write Manufacturing documents, review tooling designs, production line design, production documentation, etc.)
- Design production line and work with factory to set up, start up and maintain production line. Develop and implement assembly line automation where appropriate.
- Implement product changes including hardware, firmware, software and collateral material.
- Analyze returned products to determine the cause of failure. Document the analysis in the customer complaint record.
- Establish and execute cost reduction programs to constantly reduce COGS
- Perform supplier selection.
- Perform supplier audits.
- Establish metrics for Manufacturing Engineering and report on those metrics
To apply for this position please submit your résumé via e-mail: careers@circadiance.com
» return to the top of this page
Product Development Engineer I
Function:
Design new products and support the production of existing products. This includes new product development processes, design engineering, operations engineering, procurement engineering, and quality engineering.
Key Performance measure:
Robust designs the meet or exceed customer expectations from a performance, safety, and usability standpoint.
Education requirements:
Degree in Mechanical/Plastics Engineering
Experience:
1-3 years relevant experience
Abilities:
- Must be able to solve complex technical problems with little direction. Must be able to effectively communicate to allow for timely and quality decision-making.
-
Key behavioral skills:
- problem solver, not a problem finder mindset
- proactive
- positive attitude
- effective communication skills
Job Duties:
- Create, develop, and implement robust designs into full manufacturing.
-
Key Design skills necessary for success:
- ability to design components using a CAD system
- ability to conduct analysis of the design (this includes but is not limited to dimensional analysis, FEA, mold flow, and CFD)
- ability to integrate safety risk management into the design
- ability to design for manufacturing, assembly, and test
- ability to design for reliability
- ability to design for cost
- ability to ensure product usability elements are evaluated during the design process
-
Key Testing skills necessary for success:
- ability to create tests that appropriately test each requirement
- ability to create the test procedures
- ability to create the test reports
- ability to create the V&V plan
- ability to execute all aspects of V&V, this includes but is not limited to all protocols and reports
- ability to identify equipment needs in advance of test execution
- Work with manufacturing to create the manufacturing process and assembly procedures to ensure Design for manufacturing and assembly has been analyzed properly and implemented appropriately.
- Ability to design components and systems that are geared towards a high-volume environment.
- Review and recommend purchase of state of the art hardware and software systems for Design/Drafting.
- Assist in the understand the existing IP landscape and create designs that improve the IP position of the company
- Assist/Lead the procurement of materials and components that are needed for new products and improvements to existing products.
To apply for this position please submit your résumé via e-mail: careers@circadiance.com
» return to the top of this page
Product Development Engineer II
Function:
Design new products and support the production of existing products. This includes new product development processes, design engineering, operations engineering, procurement engineering, and quality engineering.
Education requirements:
Degree in Mechanical/Plastics Engineering
Experience:
At least 5 years relevant experience
Job Duties:
- Create, develop, and implement robust designs into full manufacturing
- Design components using a CAD system
- Conduct analysis of the design (including but is not limited to dimensional analysis, FEA, mold flow, & CFD)
- Integrate safety risk management into the design
- Design for manufacturing, assembly, and test
- Design for reliability and cost
- Ensure product usability elements are evaluated during the design process
- Create tests and test procedures
- Create test reports
- Create V&V plan
- Work with manufacturing to create the manufacturing process and assembly procedures
- Review and recommend purchase of state of the art hardware and software systems for Design/Drafting.
- Understand the existing IP landscape and create designs that improve the IP position of the company
- Lead the procurement of materials and components that are needed for new products and improvements to existing products.
To apply for this position please submit your résumé via e-mail: careers@circadiance.com
» return to the top of this page
Product Manager
Function:
The Sr. Product Manager will ensure the balance between tactical and strategic management of the business. This position is heavily strategic and is responsible for setting vision, plan development and execution of programs and processes that will drive the worldwide business forward.
Experience:
- 5-7 years Global Marketing Experience
- 3-6 years sales experience
Education:
Job Duties:
- Lead marketing role in commercialization of new products.
- Responsible for short and long term plans to meet financial objectives- worldwide in scope
- Responsible for effective marketing mix development and implementation
- Responsible for portfolio planning of the assigned product line and must understand, articulate and document where technologies and the business will evolve and establish the roadmap to achieve that vision
- Full responsibility for worldwide commercialization of new products
- Responsible for all marketing mix activities
- Product forecasting, annual market (business) plan development and implementation
- Project team participation and associated NPD activities
To apply for this position please submit your résumé via e-mail: careers@circadiance.com
» return to the top of this page
