Koya Medical
Manufacturing Engineer
Dallas, TX
·
Full time
Company website
Koya is a launch-stage health technology startup that has developed novel, 510(k) cleared wearable medical devices to address a significant unmet medical need to treat serious underlying chronic venous and lymphatic condition that spans home-health, consumer, and clinical/hospital use settings. Our team is composed of founders and seasoned professionals that have successful product development, launch, and exit track records. Our Vision + Culture We deeply care about the healthcare crisis affecting lives in our country. The economic burden continues to balloon and eats into our collective productivity. Our vision is to solve this crisis by advancing technologies that are far superior and more cost-effective than standard-of-care. We value integrity, humility, hard-work, camaraderie, and fun. Join us to make healthcare work for everyone.
Description
We are looking for a highly capable, driven, and detail-orientated Manufacturing Engineer to join our growing organization and become a key contributor to Koya Medical’s future success.
The Candidate will work independently and alongside others to assist with the daily operations of the Koya production environment. The ideal candidate will have a strong background in the processing and manufacturing of medical devices. The Manufacturing Engineer will lead the design and implementation of Koya Medical’s production equipment. Additional responsibilities include troubleshooting and improving equipment and processes, updating line layouts and process flow, tracking Cycle/Takt time calculations, and generating reports and presentations.
Responsibilities
● Conceptualize new processes, equipment, tools and fixtures for the manufacturing of Koya products using material knowledge and innovative mechanical and electrical design.
● Build, test, qualify and validate production equipment.
● Drive the execution of all aspects of production line development, training, improvements, and IQ/OQ/PQ procedures.
● Plan, coordinate, and execute activities in support of project goals.
● Support new product development by reviewing and evaluating prototypes and processes suitable for production implementation.
● Participates in coaching and training of production operators and associated production staff.
● Appropriately documents all equipment and processes in line with Koya’s Quality System.
● Performs troubleshooting of equipment and tools.
● Implements process improvements through the CAPA process.
● Works with suppliers to resolve design/production issues of supplied materials.
● Creates and drives to conclusion production NCMRs, deviations, and reworks.
● Creates operational and manufacturing engineering presentations and reports.
● Other duties may be assigned.
Requirements
● Bachelor’s Degree or higher in a mechanical, industrial or similar relevant engineering field from a 4-year university.
● 5+ years of manufacturing engineering or manufacturing operations experience working in a medical device or similar regulated environment (e.g. aeronautical).
● Strong proficiency with using SolidWorks (3 years+ preferred).
● Knowledge of statistical techniques and design of experiments.
● Solid background of operating within US and international quality standards for the development of Koya Medical’s devices and processes (21 CFR Part 820 and ISO 13485).
● Excellent verbal and written communication skills. Strong presentation skills are required.
● Skilled with computers and Microsoft Office including Word and Excel.
● Experience with electronic MRP/ERP systems.
● Understanding of Lean Manufacturing (Green Belt+ preferred)
● Excellent interpersonal and collaboration skills.
Physical Demands
● Varied sitting, standing, and walking
● Ability to lift and carry up to 50lbs.
Salary
$100,000 - $110,000 per year