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• Senior Manager, Manufacturing
• Associate Engineer / Technician
• Electromechanical Assembler
• Mechanical Assembler
• Disposable Manufacturing Technician
• Senior Scientist / Group Leader
• Scientist
• Research Associate
• Marketing Manager/Director
Senior Manager, Manufacturing
Responsible for all aspects of the manufacture of IQuum’s Liat™ Analyzer systems, including building operational systems, metrics, processes and control capabilities related to material, labor and overhead; developing and implementing production schedules; hiring and training manufacturing employees; and complying with all quality system and safety requirements.
Requirements:
- BS Degree in Mechanical Engineering preferred or BS Degree in manufacturing/operational discipline.
- 10+ years direct manufacturing experience with demonstrated track record of success; at least 5 years manager-level experience responsible for leading instrument manufacturing teams.
- Experience in a medical device manufacturing environment and ability to lead teams in a technically complex and fast-paced environment
- Extensive technical knowledge in electro-mechanical instrumentation, including PCBA, surface mount technologies, optics and other aspects of complex instrument manufacturing
- Working knowledge and direct experience with GMP, ISO13485 and other process and documentation requirements for the FDA and other regulatory bodies
- Ability to establish, measure and manage key operational metrics related to production including yields, materials utilization, inventory management, build planning and other operational areas
- Highly proactive and energetic leader with ability to quickly identify and solve operational challenges in a high growth environment
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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 volume production. There are several openings for this position.
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 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 preparation and processing of reagent solutions for manufacturing disposable tubes in accordance with manufacturing work instructions. Will set-up and operate manufacturing and testing equipment and perform incoming quality inspections on raw materials while maintaining appropriate inventory of raw materials.
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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Marketing Manager/Director
Responsible for implementing marketing/sales strategy and revenue growth plans for IQuum’s rapid, near patient, molecular diagnostics products.
Requirements:
- BS/BA required, MBA preferred
- 7-10+ years progressive commercial launch and marketing experience with majority of years with in vitro diagnostic company
- Experience in a medical or diagnostic product market and landscape where the goal was to change "accepted" clinical practice; international and domestic diagnostics market experience preferred
- Comprehension of clinical application and utility of in vitro diagnostics product and ability to communicate on a technical level with leading clinicians to convey IQuum’s value proposition
- Demonstrated ability to execute and meet or exceed strategic and financial goals in a technically complex and fast-paced environment
- Knowledge of CMS and insurance reimbursement regulations
- Polished professional with strong communication, presentation, collaboration and influence management skills and knowledge of developed market models
- Travel required up to 50% of time
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