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.
Responsible for leading process engineering and future semi and automation projects. Partner with Product Development for transfer and validation activities for new product launches. 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 commercial manufacturing departments.
Essential Duties and Responsibilities
• Develop, implement and maintain equipment, methods, operation sequences and processes in the manufacture of cartridges.
• Establish proper in-process inspection steps and SPC methods to ensure product quality and process control.
• Lead project teams as part of manufacturing process development, automation, and quality improvements.
• Evaluate product transfer designs for quality and manufactureability. Advocate for change where needed to ensure new products are designed to be easily and consistently manufactured.
• Troubleshoot issues that arise within the development and subsequent transfer of the manufacturing processes.
• Apply various tools (example DOE) to evaluate production/process 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, Validation Protocols/Reports and other documentation as part of the Design Transfer for new product introductions.
• Follow cGMP and ISO standards.
Key Qualifications & Experience Requirements
• Bachelor’s or advanced degree in a mechanical, chemical or relevant engineering field with 8 years of experience in the medical device/biotech industry preferred
• Experience in gathering design specifications and establishing manufacturing processes that are capable of delivering high quality products.
• Experience in designing and/or implementing new fixtures or automation equipment.
• Experience with evaluating and transferring molded plastic components, PCBs and other consumables into manufacturing environments.
• Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions.
• 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 in international markets is a plus.
• Strong influencing and interpersonal skills and the ability to work well with others in a proactive, positive and constructive manner.
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.