At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Opportunity:

Execute injection molding tool validation for commercial parts

Interact with external vendors to plan and manage timelines and deliverables.

Generate and release engineering drawings and documents including BOM, validation protocols and reports

Design and validate consumable fluidic devices for IVD assays

Provide feedback based on DFM analysis for design optimization, including process improvement opportunities and innovation on commercial products.

Drive troubleshooting, failure analysis, root cause investigation, issues closure and corrective action processes with internal engineering teams and suppliers.

Develop and validate test methods (e.g., custom scripting, Gauge R&R)

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.

Support and collaborate with suppliers on IQ/OQ/PQ validation tasks for injection molding.  Ensure proper documentation is completed to meet quality requirements. (e.g., Design Reviews, Engineering Drawings, FMEA, Mfg Procedures, etc.).

Who You Are:
(Required)

Bachelor’s degree (minimum) in Mechanical Engineering with 3-5 years of experience; expertise in injection molding validations for IVD products is desirable.

Technical knowledge and experience in manufacturing with general understanding of plastics engineering, injection molding tool design & construction and injection molding processes.

Strong experience with project management skills. Ability to manage competing priorities and communicate project status effectively.

Proficiency in CAD tools (SolidWorks preferred) and familiarity with drafting standards (ASME Y14.5 and GD&T); experience with PDM systems like SolidWorks PDM is a plus.

Expertise in analyzing mechanical parts and assemblies using root cause analysis techniques and modeling tools.

Demonstrated ability to analyze testing results, create accurate, thorough, and concise documentation of engineering designs and data.

Strong problem-solving and time management skills, capable of shifting priorities dynamically in a fast-paced environment while delivering timely and accurate work.

Exceptional communication and collaboration skills to establish effective relationships across all organizational levels.

WORK ENVIRONMENT:

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 35 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus.

Relocation benefits are not available for this job posting.

The expected salary range for this position based on the primary location of Carlsbad, California is $71,100 to $141,300.  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 at the link provided below. Benefits

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. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.