Senior Process Engineer
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POST DATE 8/17/2016
END DATE 10/8/2016
GenMark Diagnostics, Inc.
GenMark Dx s mission is to become the market leader in providing high value, simple to perform, clinically relevant multiplexed molecular tests to aid in the diagnosis of disease and the selection and dosing of therapies. GenMark Dx s proprietary eSensor technology is based on the principles of competitive DNA hybridization and electrochemical detection. Our eSensor technology is highly specific for the target biomarker and is not based on fluorescent or optical detection. As a result, our diagnostic tests are less prone to sample contamination risk and do not require many of the time-consuming washing and preparation steps required by competing multiplexing technologies.
Come work with the most innovative engineering and scientific team in molecular diagnostics! We are breaking new ground in sample to answer platforms using our proprietary eSensor technology. We need a senior level Process Engineer who is able to drive stable, reliable production processes for new manufacturing processes recently transferred to production. Part of this role will be to develop subject matter expertise for the company on new-to-GenMark manufacturing technologies. The team this function is part of is highly collaborative, innovative, humble, engaged and focused on customers. This is a dynamic career opportunity for a Medical Device Senior Process Engineer to come in and make an immediate impact in this high visibility position.
Under minimal supervision from senior contributors, the Senior Process Engineer will serve as the lead for an ePlex manufacturing work center. Apply hands-on leadership and involvement in process development, creation and maintenance of input and output specifications, capacity analyses, prototyping, troubleshooting, testing, and on-market support for existing products and new lines of instrumentation.
If you seek a dynamic role where your contributions will pave the way in developing new products, systems, and processes, come work with us at GenMark!
Responsible for leading process engineering projects, lean manufacturing line improvements, scrap reduction, and future automation projects. Partner with Product Development for transfer and validation activities for new product launches. Key activities will involve coordinating process improvements activities of existing product lines, partnering with outside experts to design and implement new pieces of automation equipment, assessing production for quality improvements, and validations for new product(s) within the development pipeline. This position will be instrumental in communicating with key decision makers within a matrix environment, bridging the lines of communications between, quality assurance, research/development, and the commercial manufacturing departments.
Essential Duties and Responsibilities
* Continuously improve production processes in manufacturing
* Lead project teams as part of product improvements, automation, and quality improvements
* Troubleshoot issues that arise within the manufacturing process
* Apply various tools (example DOE) to evaluate production capacities and capabilities
* Apply standard project management tools and principles to ensure project success
* 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.
* Lead change control activities within cross functional departments
* Create and approve Product BOM s, Specs, Work Instructions and other documentation as part of the Design Transfer for new product introductions.
* Follow cGMP and ISO standards
Key Qualifications & Experience Requirements
Education and Experience:
* Bachelors in Engineering, plus a minimum of 8 years related experience.
* Experience in designing/implementing new fixtures using Solidworks.
* Experience designing/implementing automation equipment is a plus.
* Chemical Familiarity with multi-step organic chemical purification is a plus.
* Experience with evaluating and transferring molded plastic components, PCBs and other consumables into manufacturing environments.
* In-depth experience with process and product validations, specification setting and test method validations, statistical process control techniques and FDA design control documentation is required.
* Project Management successes with expertise influencing key decision makers within a matrix environment.
* Working knowledge of pharmaceutical/medical device cGMPs and FDA compliance is strongly preferred.
* Strong quality-orientation with attention to detail and a desire to deliver service excellence is essential.
* Experience with design transfer activities for medical devices is a plus.
* Strong influencing and interpersonal skills and the ability to work well with others in a proactive, positive and constructive manner.
* Demonstrated experience leading process improvement initiatives across the supply chain and manufacturing operations.
* Must be able to lead cross-functional teams in problem solving, development of improvement plans and root cause-analysis.
* Demonstrated ability to support product launches and provide technical support in troubleshooting and resolving tooling/equipment issues.
* Problem Solving Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions.
* Must be able to provide technical root-cause analysis for production equipment and system issues, as well as customer complaint investigations.
* Must be proficient in the use of computer software programs such as Word, Excel, Visio, PowerPoint and using statistical software such as MiniTab or JMP.
* Must be a hands-on, self-directed, organized and conscientious individual.
* Complete work in a timely, accurate and thorough manner.
* Must be able to think and work both tactically and strategically to provide financial and operational needs to GenMark s business.
* Strong time management and organizational skills in a dynamic, constantly changing environment.
* Strong communication skills including the ability to communicate with all levels within the organization.
* 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.
* Ability to work effectively, exhibit a professional manner and establish constructive working relationships.
* Strong problem-solving, judgment and decision making skills are required.
* May lead an assigned team.
AN EQUAL OPPORTUNITY EMPLOYER
All employment decisions are made without regard to race, color, religion, sex, sexual orientation, national origin, age, creed, ancestry, marital status, non-job-related handicap or disability, veteran status, or any other legally protected status.
GenMark is an Equal Opportunity Employer and Prohibits Discrimination and Harassment of any kind: GenMark is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at GenMark are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by