Mechanical Engineer II
Carlsbad, USA
Job description
The Position
We are looking for a highly motivated and team-oriented individual who is passionate about technology and product development for IVD assays. As a Mechanical Engineer II, you will work under supervision from senior contributors for concept-to-market and sustaining engineering efforts of IVD instrumentation. Apply 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 & Responsibilities:
Design consumable fluidic devices for IVD assays
Drive the manufacturing of plastic consumables via injection molding and laser welding
Provide feedbacks based on DFM analysis for design optimization
Drive troubleshooting, failure analysis, root cause investigation, issues closure and corrective action processes as required.
Generate and release engineering drawings and documents including BOM, test reports, validation plans
Develop and validate test methods (e.g., custom scripting, Gauge R&R)
Execute testing and summarize the results
Interact with external vendors to plan and manage timelines and deliverables
Interact with suppliers and contract manufacturers to ensure parts and assemblies can be reliably produced against material specifications.
Contribute to 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.
Provide engineering and troubleshooting support to assay integration and development teams.
Minimum Qualifications:
Education and Experience:
Minimum of BS degree with 3-5 years of experience in Mechanical Engineering
Experience in designing and manufacturing of fluidic cartridges for IVD products is a plus
Skills – Technical:
Motivated to contribute in designing, developing, and sustaining medical or in-vitro diagnostics instrumentation working within an ISO 13485/GMP compliant environment.
Experience in designing and implementing complex fluidic systems utilizing custom manifolds with pumps, valves, sensors, temperature control elements, and other components
Ability to utilize root cause analysis techniques for mechanical parts and assemblies.
Experience with the mechanical design of parts and assemblies; applying principles of mechanics, thermodynamics, microfluidics, and materials.
Experience in data acquisition and instrument control programming platforms, such as Lab VIEW or Matlab, is desirable.
Experience with CAD (SolidWorks preferred), including drafting to ASME Y14.5 and GD&T standards.
Experience with PDM systems, specifically SolidWorks PDM, is desirable.
Experience with modeling tools (e.g. FEA, CFD) is a plus.
Experience with microfluidics systems is a strong plus.
Skills – General
Hands-on, self-directed, organized, conscientious.
Strong problem-solving, judgment and decision-making skills.
Consistent delivery of timely, accurate and thorough work product.
Production of accurate, complete, and concise documentation of results.
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 both orally and in writing.
Ability to work effectively, exhibit a professional manner and establish constructive working relationships.
Relocation benefits are not offered for this role. The expected salary range for this position based on the primary location of Carlsbad, CA is $94,640 and $118,300. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed here: Benefits
Who we are
GenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses. GenMark’s ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California.
GenMark is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.