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Your Opportunity

This role shift is a 2nd Shift from 2:00 PM to 10:00 PM.

As a Process Engineer I you are driving stable, reliable production processes. You are instrumental in troubleshooting, testing, and supporting existing products and new product lines. Under minimal direction, you will apply engineering principles to resolve sophisticated manufacturing equipment issues and implement initiatives to reduce equipment downtime and improve throughout. 

Also, you are:

Investigating, troubleshooting, and resolving issues that arise within the manufacturing process and optimally communicating findings. Assisting with problem solving and root cause analysis using tools (ex. 5 WHY, Fishbone Diagram…etc), DOEs (Design of Experiments), analyzing data, and development/implementation of sustainable countermeasures.   

Applying statistical methods to various production performance datasets to supervise, track trend, and/or assess opportunities for improvement in capacity, yield, and/or utilization. 

Performing validation (IQ/OQ/PQ) protocols, test method validations, test protocols, and associated activities for new or improved processes and manufacturing equipment. 

Participating in project teams as part of product improvements, automation, and quality improvements. Also, you are supporting process development, characterization & improvement activities to both new and existing product lines. To ensure project success, we apply standard project management tools and principles 

Serving as advocate and role model for integrating change into the organization as well as serve as departmental role model of professional behavior and presence. You are training manufacturing and maintenance personnel as needed.

Document management: You will create, and approve Product BOM’s, Specs, Work Instructions and other documentation as part of the Design Transfer for new product introductions.

Who you are 

As an ideal candidate, it is preferred that you hold a Bachelor’s degree in Engineering or a related technical field and bring 1+ years of related industry experience and background.

Equivalent industry experience (5+ years) with a high school diploma is acceptable.

The experience you bring is in crafting/implementing manufacturing processes, equipment and fixtures.

It's strongly preferred that you are knowledgeable of pharmaceutical/medical device cGMPs and FDA compliance.

Other pluses: Experience with design transfer activities for medical devices and  designing/implementing automation equipment.

Behaviors, competencies, and qualities of the ideal applicant

Must be proficient in the use of SolidWorks or equivalent CAD software, Word, Excel, Visio, and PowerPoint. 

Familiarity with experimental design, data analysis, and interpretation of experiments; Proficient in the use of statistical software such as JMP is plus. 

Strong quality orientation and a desire to deliver service excellence. Familiarity with Lean Six Sigma or Six Sigma DMAIC methodology is a plus.

You have great organizational skills in a dynamic, constantly changing environment. You are an effective communicator for sensitive inquiries, customer inquiries or complaints as well with management, peers, and individuals. You can work effectively, exhibit a professional manner and establish constructive working relationships.

Relocation benefits are not available for this posting.

The expected salary range for this position based on the primary location of California is $65,200-121,000. 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. Relocation benefits are not offered for this job posting. 

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 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.