This new exciting role at GenMark will work under minimal supervision from senior contributors and serve as a mechanical engineer for concept-to-market and sustaining engineering efforts of IVD consumables and instrumentation. This individual will be responsible for applying hands-on involvement in on-market support for existing and new products, troubleshooting and root cause analysis, creation and maintenance of input and output specifications, concept and feasibility activities, prototyping, testing, and transfer to manufacturing.
Essential Duties and Responsibilities
Define the requirements for the production of new tooling and part design and deliver high quality plastic injection molded products in a timely and cost-efficient manner.
Work with production teams to transfer verified designs into full production using principles of DFM/DFA.
Participate in failure analyses, First Article Inspections, and test method development.
Transfer troubleshooting knowledge to Customer Technical Support (CTS) and assist CTS, production, and contract manufacturers as new problems arise.
Interact with suppliers and contract manufacturers to ensure parts and assemblies can be reliably produced against material specifications.
Complete the product design, analysis and development of components and assemblies, including assembly and part drawings as well as other required documentation from design concept to manufacturing transfer.
Perform and document feasibility, design, verification, validation, and risk analysis activities under design controls within the new product development process potentially working alongside outsourced partners.
Develop test and development strategies and plans of substantial scope and duration that may include coordinating contributors across teams and outsourced partners.
Comprehensive understanding of assigned products, including interrelationships with systems developed by other contributing teams.
Provide engineering and troubleshooting support to assay integration and development teams.
Education and Experience:
Highly skilled at designing, developing, and sustaining medical or in-vitro diagnostics consumables and instrumentation working within an ISO 13485/GMP compliant environment.
Demonstrated experience in root cause analysis techniques for mechanical parts and assemblies.
Expert level experience with the mechanical design of complex parts and assemblies; applying principles of mechanics, thermodynamics, microfluidics, and materials.
Demonstrated experience in the design, DFM, and production of injection molded plastics, including rapid prototyping, prototype molding, and multi-cavity production molds.
Experience with plastic assembly techniques such as ultrasonic and laser welding.
Experience in data acquisition and instrument control programming platforms, such as LabVIEW or Matlab.
Experience with CAD (SolidWorks preferred), including drafting to ASME Y14.5 and GD&T standards.
Experience with PDM systems, specifically SolidWorks PDM, is desirable.
Proficient with root cause analysis, design of experiments, data analysis, and tolerance analysis techniques.
Experience with modeling tools (e.g. FEA, CFD).
Experience with requirements management, verification, and validation.
Experience with microfluidics systems a strong plus.
Hands-on, self-directed, organized, conscientious.
Strong problem-solving, judgment and decision-making skills.
Consistent delivery of timely, accurate and thorough work product, including accurate, complete, and concise documentation.
Ability to think and work both tactically and strategically to meet financial and operational needs for GenMark's business.
Strong time management and organizational skills in a dynamic, continually changing environment.
Strong communication skills including the ability to communicate with all levels within the organization.
Ability to respond effectively to sensitive inquiries, customer inquiries or complaints as well as communicate effectively both orally and in writing with management, peers and individuals.
Ability to work effectively, exhibit a professional manner and establish constructive working relationships.
The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. This position may involve a combination of office and biotechnology laboratory environments. The employee may be exposed to hazardous chemicals, blood borne pathogens and automated equipment.
While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus.
The work environment and physical demands described are representative of those required by an employee to perform the essential functions of this job with or without reasonable accommodations.
We are interested in every qualified candidate, who is eligible to work in the United States. However, we are not able to sponsor visas at this time.
Genmark Diagnostics, Inc.