Director Of Manufacturing Engineering

Company: Ortho Development Corporation
Location: Draper
Posted on: May 8, 2022

Job Description:

Ortho Development Corporation is motivated to help people do what they love by restoring mobility. We are passionate about designing and manufacturing the best, clinically-proven, high-performance orthopedic devices in the world. Our product focus is total hip and knee replacement; along with trauma fracture repair, and spine treatment. The successful candidate will represent the Manufacturing Engineer team at Ortho Development Corporation. The Director of Manufacturing Engineering is a highly motivated, technically competent team builder who can establish and execute a strategic vision, multi-task in a fast-paced work environment, and deliver tangible results. The Director of Manufacturing Engineering will be accountable for safety, quality, cost delivery, responsiveness, performance, continuous improvement, and development of the Manufacturing Engineering team. Specific areas of responsibility are all production processes and functions, including those in the Ortho Development machine shop, clean room, material handling, preventative maintenance, and at outside suppliers. Principal Responsibilities: Direct the Manufacturing Engineering team; help them gain skills and experience necessary to operate independently Ownership of the Validation Master Plan a. Update and maintain the plan per need and applicable regulations ISO 13485 and 21 CFR b. Oversee the development and execution of all qualification activities including IQ/OQ/PQ as well as requalification Technical expert for all production processes including resource for outside suppliers Support the preventative maintenance team as needed Work with executive management to help plan expansion and cost savings strategies. And then lead the execution and track according to the plan Work with Quality to continuously evaluate cost of quality and opportunities for continuous improvement; strive for cost savings through better quality and efficiency including make/buy ratio and lead-times Support Product Development with DFM and design transfer Support Manufacturing Engineering involvement in product cross-functional teams including new product development and sustaining activities Support Quality Engineering activities including nonconformance reviews, change evaluations, and supplier change requests Create a culture that is congruent with ODEV Values and Code of Conduct, not only with the ODEV team, but also with outside suppliers Experience/Training specific to this position: Bachelor's Degree or equivalent experience in Engineering or other scientific/ math/ statistics Minimum 10 years Bachelors Degree or 14 years in Medical Device field or other regulated industry such as Aerospace Project management from inception to completion & tracking Managing other engineers Manufacturing Processes; forging/casting, metal and plastic machining, polishing, (ceramics preferred) Process Qualification/Validation including IQ/OQ/PQ Statistics for quality including SPC and DOE Design engineering/CAD (Creo Preferred) Basic knowledge of orthopedic total joint reconstruction preferred Construction, validation, and operation/maintenance of cleanrooms preferred Infrastructure project experience: water (RO/DI), compressed air, air handling, power, etc.Preferred Additional Information We offer competitive compensation and excellent benefits including: Medical, Dental and Vision Insurance Health Reimbursement Account Flexible Spending Account Company paid Life and AD&D Insurance Long Term Disability Insurance Tuition Assistance 10 Paid Holidays 15 days PTO to start Quarterly Bonuses Employee Discounts 401K and 401K match Employee Assistance Program Wellness Coaching and Gym incentives

Keywords: Ortho Development Corporation, Draper , Director Of Manufacturing Engineering, Executive , Draper, Utah