We are currently seeking an experienced, extremely capable, self-motivated, and personable Production Engineer to oversee and improve quality and scalability of production processes. This wide-ranging, hands-on position includes everything from making our manufacturing processes and tools more efficient, to interfacing with our contract manufacturers, to performing root cause analysis, to selecting alternative components due to end of life or out of stock. Our best-in-class wearable human movement monitor includes technologies such as extremely high density PCBAs, wireless embedded systems powered by lithium batteries, injection molded cases, and 3D printed components. Our local production infrastructure includes assembly technologies such as custom PCBA test fixtures, epoxying processes, laser marking, and inertial calibration equipment, all of which are under an ISO 13485:2016 quality system. Thus, we are particularly interested in a Production Engineer who has deep experience with high density electronic assemblies, soldering, and quality systems. We are searching for a qualified and innovative candidate to immediately fill this open position. This is a full-time, salaried position with benefits.
Duties and Essential Functions:
· Analyze and Improve production processes and procedures to increase throughput and reduce cost while efficiently producing consistent high quality products. Coordinate product design transfer to manufacturing with emphasis on quality, cost-reduction, and scalability.
· Work with engineering to implement version changes, replace end-of-life components, and introduce new products into production.
· Investigate and troubleshoot to solve any unforeseen problems that arise with product design or implementation. Help debug production issues as necessary, including documenting and troubleshooting of issues.
· Work with customer service and engineering to examine and perform root cause analysis for product RMAs and manufacturing issues. Complete root cause defect analysis of fixture and part failures.
· Support our testing infrastructure of PCBA test fixtures, assembly tooling, and calibration systems.
· Work with Quality and Production Managers to ensure Production follows the company’s Quality Management System. Take ownership and responsibility for CAPA activities as well as change requests.
· Work closely with contract manufacturers who manufacture our subassemblies, such as PCBAs, molded plastic cases, high strength glass lenses, batteries, strapping system, shipping cases, etc.
· Write, document, and implement QA standards and guides for internal team and external vendors.
· Work directly with product and inventory managers to ensure timely communication with vendors on defect quality reporting, track and analyze vendor performance results, and monitor manufacturing runs to guarantee that we always have inventory on the shelf and ready to go.
· Prototype, optimize, hand-off and train new production processes and techniques to production staff.
· Collaborate with new product engineers to determine critical part features and review manufacturability of design.
· Develop manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment. Research and test manufacturing and assembly processes to improve or modify current methods.
· Design and implement software, firmware, electrical and mechanical systems as infrastructure equipment to suit production requirements.
· Assure product and process quality by designing testing methods, testing finished-product, establishing standards, and verifying manufacturing processes.
· Regularly review and update documentation (including standard operating procedures, work instructions, incoming material quality inspection, and testing instructions).
· Maintain accurate Bills of Materials.
· Serve as a backup production resource as needed.
· At least 3 years hands-on experience as a production engineer or equivalent, with an emphasis on modern PCBA and assembly production technologies. This includes PCB fabrication, automated PCBA assembly, injection molding, epoxying processes, CNC, and 3D printing.
· Bachelor's Degree in Engineering or the equivalent discipline. A degree in electrical engineering is strongly preferred, but not necessary.
· Extremely knowledgeable about, and proficient with, through-hole and surface mount RoHS soldering. IPC certification is a big plus.
· Experience with medical devices and quality systems, especially ISO 13485:2016.
· Proficient with ECAD, preferably EAGLE CAD. Proficiency with MCAD, preferably SolidWorks, is a plus.
· Familiarity with Linux and the open source ecosystem used in our production infrastructure (including Git, Python, and Bash).
· Familiarity with standard software tools such as ERP, versioning systems, issue trackers, wikis, spreadsheets, etc.
· Must be a strong communicator, with effective writing skills.
· Must be self-organized and self-motivated, and able to be a strong contributor to our highly collaborative production team.