Process Engineer I Jobs

The Process Engineer I will be responsible to drive stable, reliable production processes 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 creating and maintaining process input and output specifications, perform capacity analyses, troubleshoot, test, and support for existing products and new product lines. This position will sustain and continuously improve process for existing products.

POSITION REQUIREMENTS

• Apply standard project management tools and principles to ensure project success.
• 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.
• Lead change control activities within cross functional departments.
• Execute validation (IQ/OQ/PQ) protocols, test method validations, test protocols, and associated activities for new or improved processes and manufacturing equipment.
• Create and approve Product BOM’s, Specs, Work Instructions and other documentation as part of the Design Transfer for new product introductions.
• Serve as advocate and role model for integrating change into the organization as well as serve as departmental role model of professional behavior and presence.
• Support process development, characterization & improvement activities to both new and existing product lines.
• Training manufacturing personnel.
• Partner with outside experts to design and implement new automation equipment.
• Assist with 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.
• Participate in project teams as part of product improvements, automation, and quality improvements.
• Troubleshoot and investigate issues that arise within the manufacturing process and effectively communicate findings in a timely manner.
• Partner with Product Development for transfer and validation activities for new product launches.
• Follow cGMP and ISO standards.

Education and Experience

• Material Science knowledge is a plus.
• Experience designing/implementing automation equipment is a plus.
• Experience with surface treatment (i.e. plasma, CO2 cleaning), laser bonding and dispensing is a plus.
• 1+ years of related experience, background and industry is preferred.
• Bachelor’s degree in Engineering or related technical discipline.
• Chemical – Familiarity with multi-step organic chemical purification is a plus.
• Experience in project management with expertise influencing key decision makers within a matrix environment is preferred.
• Working knowledge of pharmaceutical/medical device cGMPs and FDA compliance is strongly preferred.
• Experience with design transfer activities for medical devices is a plus.
• Experience in designing/implementing manufacturing processes, equipment and fixtures.

Skills – Technical

• Must be able to support cross-functional teams in problem solving, development of improvement plans and root cause-analysis.
• Proficient in the use of SolidWorks or equivalent CAD software.
• Must be proficient in the use of computer software programs such as Word, Excel, Visio, PowerPoint.
• Problem Solving – Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions.
• Familiarity with experimental design, data analysis, and interpretation of experiments; Proficient in the use of statistical software such as JMP is plus.
• Demonstrated ability to support product launches and provide technical support in troubleshooting and resolving tooling/equipment issues.
• Familiarity with Lean Six Sigma or Six Sigma DMAIC methodology is a plus.

Skills – General

• Strong quality-orientation with attention to detail and a desire to deliver service excellence is essential.
• Strong problem-solving, judgment and decision-making skills are required
• Must be able to think and work both tactically and strategically to provide financial and operational needs to GenMark’s business.
• Complete work in a timely, accurate and thorough manner.
• Must be a hands-on, self-directed, organized and conscientious individual.
• Strong time management and organizational skills in a dynamic, constantly changing environment.
• Strong influencing and interpersonal skills and the ability to work well with others in a proactive, positive and constructive manner.
• Ability to work effectively, exhibit a professional manner and establish constructive working relationships.
• Strong communication skills including the ability to communicate with all levels within the organization.
• Strong time management and organizational skills in a dynamic, constantly changing environment.
• Ability to read, write and analyze complex documents.
• 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.

CERTIFICATIONS, LICENSES, REGISTRATIONS (if applicable)

• None

SUPERVISORY RESPONSIBILITIES (if applicable)

• None

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 California is $63,800-$118,600. 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.