Senior Process Engineer

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A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.

The Opportunity:

The Senior Process Engineer will be responsible for driving stable and reliable production for new manufacturing processes recently transferred to production. Under minimal supervision, the Process Engineer will use sound and proven engineering principles to develop and characterize manufacturing processes, including surface treatment (i.e. plasma, CO2 cleaning) and precision dispensing of fluids and adhesives. This position will be instrumental in the following: creating and maintaining process input and output specifications; performing capacity analyses; troubleshooting, testing, and support for existing products and new product lines.

This is an onsite position based in Carlsbad, CA.

Relocation benefits are not available for this position.

• You will drive process development, characterization & improvement activities to both new and existing product lines by leading project teams as part of product improvements, automation, and quality improvements.
• You will apply statistical methods to various production performance datasets to monitor, track and trend, and/or assess opportunities for improvement in capacity, yield, and/or utilization; you will have the ability to troubleshoot and investigate issues that arise within the manufacturing process and effectively communicate findings in a timely manner; you will apply standard project management tools and principles to ensure project success.
• You will perform problem solving and root cause analysis using tools (ex. 5 WHY, Fishbone Diagram etc), DOEs (Design of Experiments), data analysis, and development/implementation of sustainable countermeasures; you will create and execute validation (IQ/OQ/PQ) protocols, test method validations, test protocols, and associated activities for new or improved processes and manufacturing equipment.
• You will partner with Product Development for transfer and validation activities for new product launches; as well as with outside experts to design and implement new automation equipment.
• You will create and approve Product BOM's, Specs, Work Instructions and other documentation as part of the Design Transfer for new product introductions; you will follow cGMP and ISO standard and lead change control activities within cross functional departments.

Who You Are:

(Required)

• You have a bachelor's degree in Engineering (or related technical discipline) and 6+ years of related experience in process development for Medical Devices or M.S degree with 4+ years of related experience.
• You have experience in designing/implementing manufacturing processes, equipment and fixtures; a demonstrated working knowledge of pharmaceutical/medical device cGMPs and FDA compliance; and experience with surface treatment (i.e. plasma, CO2 cleaning), laser bonding and dispensing.
• You must be able to support cross-functional teams in problem solving, development of improvement plans and root cause-analysis; you have demonstrated ability to support product launches and provide technical support in troubleshooting and resolving tooling/equipment issues.
• You must be proficient in the use of computer software programs such as Word, Excel, Visio, PowerPoint; as well as SolidWorks (and/or equivalent CAD software).

Preferred:

• You have experience understanding the design process and how it impacts manufacturing.
• You have experience delivering technical presentations to project leaders to clarify issues and/or to prescribe solutions for manufacturing related problems.
• You have experience within a matrix environment; demonstrated effective verbal and written communication skills; 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.
• You have demonstrated time management and organizational skills in a dynamic, constantly changing environment.
• You have strong interpersonal skills, including: the ability to work well with others in a proactive, positive and constructive manner; a desire to deliver service excellence; and the ability to communicate with all levels within the organization.

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.

The expected salary range for this position based on the primary location of Carlsbad, CA is $78,800 - $146,300. 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 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.