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• Senior Mechanical Engineer
• Senior Electrical Engineer
• Senior Systems Engineer
• Optical Engineer
• Associate Engineer / Technician
• Electromechanical Assembler
• Mechanical Assembler
• Disposable Manufacturing Technician
• Senior Scientist / Group Leader
• Scientist
• Research Associate
• Clinical Research Associate
Senior Mechanical Engineer
As part of the Engineering team, this individual will apply fundamental engineering skills to develop solutions to design requirements. Will conduct structural and thermal computational modeling and will assist others with analytical solutions and problem solving. Responsible for part and sub-assembly design release and will manage and execute design verification and compliance test activities.
Responsibilities:
- Develops and analyzes conceptual design approaches
- Conducts experimental evaluations
- Develops detailed designs consistent with best possible cost, quality and manufacturability and conducts design verifications
- Performs design changes, revisions and drawing releases in compliance with SOPs
- Builds Engineering prototypes and develops testing requirements
- Recommends and liaises with suppliers to ensure quality parts
- Follows product life through to manufacturing release, at the same time revising and improving the product
- Provides detailed guidance and analytical support to mechanical designers
- Acts as project lead for mechanical engineering aspects of assigned projects, insuring the mechanical engineering team provides quality work within assigned timelines
- Keeps Manager informed of project status and problematic issues or concerns
- Supports manufacturing in resolving applicable design related product build issues
- Insures that final design is compliant with engineering principles and company standards
- Provides training and mentoring to Mechanical Engineers and Engineering Technicians
- Writes documentation in compliance with Quality System requirements
Requirements:
- BS Mechanical Engineering
- 10 years progressive leadership experience, preferably in medical device field
- Demonstrates capability of bringing at least 2 products to successful commercialization
- Experience in designing small, complex mechanisms
- Skills in computer aided design and analysis, preferable with SolidWorks
- Demonstrates ability of working across broad engineering disciplines to create reliable, manufacturable and robust systems
- Competence in medium-volume manufacturing processes and Reliability Engineering
- Experience in design of optical systems is highly desirable
- Experience with shipping and packaging design a plus
- Strong leadership and communication skills to effectively convey ideas across the entire team
- Experience with small plastic component design and manufacturing
- Ability to analyze data
- Familiarity with FEA, data presentation via spreadsheet, and tolerance analysis
- Experience with MS Office
- Experience with thermal transfer design with heating/cooling mechanisms
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Senior Electrical Engineer
Responsible for the electrical design of new instrumentation, this position is focused on the analysis, design and construction of engineering prototypes and their evolution into production level instruments. Liaise closely with mechanical, software and test functions to ensure smooth integration of designs into products.
Responsibilities:
- Responsible for all aspects of design and release to production of medical instrumentation circuit board assemblies
- Electrical design of subsystem components for future product development as well as design of manufacturing test fixtures as required
- Schematic capture using the ORCAD
- PC board layout with PADS
- Procures prototype circuit board assemblies for debugging
- Creates documentation to support designs & lead design reviews
- Work with vendors to assure adherence to processes
- Testing and troubleshooting analog and digital circuits
- Debug and test prototype PCBA’s and systems
- Analog and digital design of circuit boards
- Performs tolerance analysis to ensure performance at extremes of environment & stress
- Interfaces with software engineering to ensure performance of all components
Requirements:
- BS Electrical Engineering
- 10 years of progressive leadership experience in instrument design / development
- A proven track record of bringing products from concept to small-scale manufacturing
- Experience with the Regulatory Approval Process EN61010 / FDA
- Understands the fundamentals of electronics
- Demonstrated hardware design and debug skills
- Strong skills in communication and documentation
- Embedded or Real Time Software Engineering skills preferred
- Significant Design Experience in Microprocessor / Microcontroller Hardware, Optical Sources & Detectors, Medical or Laboratory Instrumentation, and/or Automation / Motion Control
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Senior Systems Engineer
Responsible for integrating the hardware and software to perform the necessary assay functions. The candidate will generate requirement documents, define and ensure system requirements are met and define test protocols. In addition, this person will drive verification and validation.
Responsibilities:
- Familiar with precision motor and heater control systems
- Experience with optical detection systems is a plus
- Analyzes data to identify system performance and recommends system design improvements
- Generates flowcharts and requirement documents to describe system performance
- Leads system design reviews
- Ability to define data structures
- Works effectively in a cross-functional team with both engineers and biologists
- Must be able to use standard laboratory tools and equipment
Requirements:
- 10-15 years experience in the integration of hardware and software to produce a medical device
- Previous experience in transfer to manufacturing
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Optical Engineer
Design and develop optical systems, including optical components, signal processing technology and other optical processes within instrumentation platform for a molecular diagnostics company.
Responsibilities:
- Works on projects from inception at the concept development stage to completion at the product delivery stage
- Plays a primary role in developing designs, technology and product concepts; for commercial and prototype products
- Assists in the manufacturing and manufacturing processes required to complete the projects
- Ensure the development of manufacturable products which meet demanded performance and cost requirements.
Requirements:
- BS or above in engineering or physics
- 5-7 years industry experience, preferably in the medical device field
- Ability to work with lab instrumentation and related components
- Strong experience developing optical and electro-optic components and systems
- Strong experience developing technology and concept proposals, as well as strong experience designing hardware for production
- Experience with designing tools
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Associate Engineer / Technician
Associate Engineer / Technician will perform complex mechanical and electrical tasks in support of product development through manufacturing release. Responsibilities include testing and troubleshooting electronic modules and sub assemblies, building prototypes, conducting engineering experiments and providing assembly feedback, recommendations and documentation.
Requirements:
- Minimum of 5 years of relevant experience in electro-mechanical manufacturing or engineering environment
- Associate degree in electrical engineering or equivalent
- Proven mechanical aptitude
- Excellent verbal and written communication skills
- Ability to troubleshoot electronics to the component level
- Fine pitch solder experience a plus
- Experience in medical industry a plus
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Electro-Mechanical Assembler
Electro-Mechanical Assembler will assemble product for prototypes, pilot runs and volume production.
Requirements:
- Previous electro-mechanical assembly experience required
- Must have some soldering experience
- Ability to work from work instructions and or blueprints
- Experience working with hand tools
- Good manual dexterity
- Ability to see and handle fine wiring and small components
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Mechanical Assembler
Mechanical Assembler will assemble products for prototypes, pilot runs and volume production. There are several openings for this position.
Requirements:
- Previous mechanical assembly experience required
- Ability to work from work instructions and/or blueprints
- Experience working with hand tools
- Good manual dexterity
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Disposable Manufacturing Technician
This individual will be responsible for the daily preparation and processing of reagent solutions for manufacturing disposable tubes in accordance with manufacturing work instructions. Will work closely with Engineers and Scientists to assemble all disposable components to satisfy requirements. Will set-up and operate manufacturing and testing equipment and perform incoming quality inspections on raw materials while maintaining appropriate inventory of raw materials. We seek an individual who is interested in assuming a leadership role as the department grows.
Requirements:
- Associates Degree or higher in Chemistry or Biology or equivalent experience
- Minimum of 2 years experience in formulations, preferably within an IVD regulated setting
- Must have strong knowledge of standard lab techniques and good computer skills
- Must be able to safely handle biohazard materials and hazardous chemicals
- Familiarity with FDA, QSR/GMP, ISO and OSHA is desirable
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Senior Scientist / Group Leader
Responsible for developing molecular diagnostic assays based on the lab-in-a-tube technology platform. This is a hands-on position. This person will design and execute lab research studies to develop and maximize applications based upon IQuum’s novel biomedical detection devices. Responsibilities include managing people and programs and providing scientific guidance to team members. This position requires hands-on experience in nucleic acid assay development and familiarity with real-time detection methods. Will require working in BSL1 and/or BSL 2 laboratories.
Requirements:
- PhD or MS in Biochemistry, Molecular Biology or related field
- 8 or more years of relevant work experience, industry experience preferred
- Must have familiarity with state-of-the-art assay technologies, including nucleic acid extraction, nucleic acid amplification and detection techniques
- Proven experience with multiplexed nucleic acid assay development and platform development strategies (clinical diagnostics market experience preferred)
- Experience with protein separation techniques such as protein chromatography and affinity purification a plus
- Previous experience in project and people management
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Scientist
Responsible for developing molecular diagnostic (IVD) assays for IQuum’s lab-in-a-tube technology platform. Will design and execute lab research studies to develop and maximize applications of novel biomedical detection devices. Requires hands-on experience in nucleic acid assay development and familiarity with real-time detection methods. Will require working in BSL1 and/or BSL 2 laboratories.
Requirements:
- PhD or MS in Biochemistry, Molecular Biology or related field
- Minimum 4 years of relevant work experience, industry experience preferred.
- Familiarity with state-of-the-art assay technologies, including nucleic acid extraction, nucleic acid amplification and detection techniques
- Proven experience with multiplexed nucleic acid assay development and platform development strategies (clinical diagnostics market experience preferred)
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Research Associate
Responsible for research and development projects based on the innovative lab-in-a-tube technology platform. Research projects will be focus primarily on the development of molecular diagnostic testing methods base on our proprietary close system platform, including all steps of assay development from concept to formal assay validation. Multiple positions are available ranging from entry to senior Level. This is a great opportunity for graduating Master's candidates who have excelled in academic studies to begin an industry career.
Requirements:
- BS or MS in Biochemistry, Molecular Biology or related field
- Some relevant experience, industry experience preferred
- Must have fundamental understanding of molecular and cellular biology methods and theory
- Broad familiarity with state-of-the-art immunoassay, nucleic acid extraction, nucleic acid amplification and protein and nucleic acid detection technologies
- Demonstrated ability to formulate innovative hypotheses and apply knowledge
- Excellent verbal, written and analytical skills
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Clinical Research Associate
Responsible for the design, implementation and monitoring of clinical trials as well as preparation of clinical and regulatory reports.
Responsibilities:
- Participate in the design and writing of protocols, case report forms and informed consent forms for clinical trials
- Productive in recruitment and selection of new investigators, contract researchers as well as the organization of the outside vendors
- Plan and implement all activities required for conducting and monitoring complex clinical trials and ensure that Good Clinical Practices (GCP) are followed
- Conducts site visits pre-study, at study initiation, at regular intervals during the study and at study closeout
- Monitor investigator performance and adherence to protocol, and proactively address study issues and enrollment problems, as necessary
- Ensure that Case Report Forms (CRF) are reviewed in a timely fashion and submitted to the data management group
- Contribute to the compilation of integrate medical reports and clinical sections of IDEs and Biological License Applications (BLAs)
- Prepare integrate medical reports, Investigational Device Exemptions (IDE), periodic reports
Requirements:
- BS in a scientific or related field
- 5-8 years' experience in the pharmaceutical or medical device industry including relevant clinical research experience
- Intermediate positions require BS in scientific field and 2-4 years related experience
- Knowledge of FDA regulatory requirements is preferred
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