Engineer II at 6270 GenMark Diagnostics, Inc. in Carlsbad, California

Job Description:

The Position

The Engineer II, Manufacturing Technical Operations, will be responsible to drive stable, reliable production processes for all of manufacturing.  Under limited supervision, the Engineer II will plan, execute, and analyze scientific experiments leading to manufacturing process improvements or resolving manufacturing problems for molecular diagnostic products.  Specifically, this individual will work cross-functionally with Manufacturing, R&D, Quality, Operations, and other departments to troubleshoot, investigate to root cause, develop solutions, and implement product and process improvements.

Your key responsibilities

• Independently plan and execute engineering experiments to characterize, troubleshoot, and optimize existing manufacturing processes.


• Seek out, propose, prototype, validate, and implement new/alternative manufacturing processes.  


• Independently analyze data, interpret results, and suggest the best path forward to senior leadership.


• Interface with cross-functional teams such as Manufacturing, Quality, R&D, and Commercial to drive process characterization and improvements.


• Collaborate with outside experts and vendors to design and implement new process, metrology, automation, and test equipment as necessary.


• Validate new or improved process, manufacturing and metrology equipment, i.e. IQOQ, VLP/VLR, Gauge R&R


• Apply various tools (example DOE, Six Sigma, Lean) to investigate issues in production.


• Draft and/or modify equipment-supporting documentation such as EAN, ES, EI, PM, VLP, VLR, MWI.

Who you are

• BS in Chemical Engineering, Materials Science, Bioengineering or related discipline with 4+ years of experience in biotechnology or semiconductor device manufacturing or MS with 2+ years of similar experience.


• Expertise in at least two of the following areas is required: surface modification, plasma cleaning, thin-film deposition, electrochemistry, polymer chemistry, electrowetting, or surface-characterization techniques (i.e. SEM, AFM, ATR-FTIR, Cyclic Voltammetry, XPS) 


• Demonstrated success in process characterization and optimization is required.


• Hands-on experience on process and metrology equipment.  Able to come up to speed quickly on the operation and maintenance of new, unfamiliar equipment. 


• Demonstrated experience in using engineering concepts to gather and analyze information, develop alternative solutions, and resolve problems promptly.


• Strong experience in testing, validating, implementing, and improving manufacturing equipment and fixturing.  Proficiency with SOLIDWORKS is a plus.


• Demonstrated experience in collaborating with process tool, metrology, and/or raw material vendors.  


• Demonstrated competence in data analysis, research design, and the evaluation of new techniques and procedures for products, systems, or technologies.


• Working knowledge and experience in molecular diagnostic products and automation are preferred.


• Ability to write study protocols, develop experimental designs, and create tech summary reports with minimum supervision.


• Understand cGMP and ISO standards for medical devices.


• Strong problem solving, judgment, and decision-making skills are required.


• Initiate, direct, and execute scientific research and/or development strategies.


• Failure investigation/product reliability activities based on field performance issues, as well as manufacturability or internal quality needs.


• Establish technical expertise; serve as a resource to other groups.


• Strong quality-orientation with attention to detail and a desire to deliver service excellence is essential.


• Must be a hands-on, self-directed, organized, and conscientious individual.


• Computer skills and familiarity with Microsoft Word, Excel, PowerPoint, graphing software and statistical analysis software (i.e. JMP).

*Relocation assistance is NOT available for this role*

The expected salary range for this position based on the primary location of California is $78,800.00 to $146,300.00.  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

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.