Manufacturing Engineer
BIOTRONIK Inc, Lake Oswego, OR, United States
Working for Micro Systems Engineering, Inc. (MSEI) means joining an elite team to work on some of the most exciting challenges in medical technology today. We are a pioneer in developing innovative implantable medical device technologies and devices that save and enhance the quality of life for millions of individuals living with cardiovascular and chronic neurologic pain disorders. With more than 40 years of experience in design and manufacturing of active implantable medical devices, our continuing success is based on our company's core values - innovation, quality, reliability, integrity, teamwork, and undisputed expertise - thus enabling us to inspire confidence and trust in physicians and patients worldwide. We are continually looking for talented engineers, scientists, and professionals to share in our mission.Please join us as:Manufacturing EngineerWe are expanding our team and seeking a Manufacturing Engineer to lead our Manufacturing Response Team within the elite Advanced Process Technologies group. In this role, you will be responsible for driving manufacturing improvements across processes, materials, and equipment to achieve product quality, reliability, production volume, delivery, and cost targets. You will play a critical role in supporting the manufacturing of Class III medical devices, focusing on yield trending, process enhancements, component technology, and manufacturing support for both processes and equipment. Your Responsibilities Work in a cross functional team to perform root cause analyses, resolve and implement product fixes, modifications, and design enhancements. Perform in depth design reviews of process and components to ensure products meet specification, are manufactured efficiently, and meet high levels of reliability. Lead yield improvement activity to reduce product variability and product cost. Evaluate and improve manufacturing systems including component traceability, manufacturing resources, production tooling and Manufacturing Execution Digital Systems Provide solution based creative designs and manufacturing techniques to meet the requirements for new products operation and new platform technologies to be used in the assembly of the medical devices. Monitor the effectiveness of new processes and equipment in a semi or fully automated assembly process to simplify and eliminate waste. Change management implementation: leading stage-gate approvals, supplier quality interface, characterization, verification, and digital factory execution. Provide inputs for, and in some cases lead, the customer communication for scoping of work, design reviews, process development, implementation, schedule, and technical reporting. Gathering data from production processes and performing trend analysis will be vital in recommending areas of improvement. Presentation of data, trends and recommendations for improvement will be conducted on a routing basis to a cross functional audience.Your ProfileEducation / Experience Requirements Minimum of Bachelor of Science degree in Chemical Eng., Materials Science, Industrial Eng., Mechanical Eng. or related physical science 4+ years of experience in a manufacturing or process development environment. Experience with working in an environment with Manufacturing Execution Systems, Enterprise Resource Planning, and Business Intelligence enterprise systems. Data analysis skills: trained in DMAIC approach with a demonstrated use of data analysis using JMP, Minitab, or equivalent.Additional Preferred Knowledge, Skills Abilities Excellent, detail oriented written and verbal communications skills. Demonstrated ability to conceive, implement, and complete engineering projects and experiments on schedule. Experience with design and build of complex, miniaturized, electro-mechanical assemblies. Knowledge of class 3 medical manufacturing quality and assembly requirements. Planning/project management skills: MS-Project, Project Management Fundamentals training Proficiency in standard office productivity software (Excel, Word, PowerPoint etc...). Demonstrated ability to interface across multiple functions/organizations (Quality, Manufacturing, Supply Chain, Test, Module/System development) to drive closure on projects. Demonstrated leadership interest and ability.Physical Requirements:The physical demands described within this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer for extended periods of time and communicate with co-workers. Must be able to work a minimum of 40 hours / week. Location: Lake Oswego(0001) Working hours: Full-time MSEI Lake Oswego Oregon (US-OR) USA Job ID: 59413 Micro Systems Engineering, Inc. is an equal opportunity employer. In accordance with applicable law, the company prohibits discrimination based on race, color, religion, creed, gender, pregnancy or related medical conditions, age, national origin or ancestry, physical or mental disability, sexual orientation, genetic information, uniformed service or any other consideration protected by federal state and local laws. Our commitment to equal opportunity employment applies to all persons involved in our operations and prohibits unlawful discrimination by any employee.Micro Systems Engineering, Inc. believes that diversity leads to strength.