Manufacturing Engineer will be responsible for the direct oversight of manufacturing operations, quality engineering, and R&D engineering for development and production of implantable medical device products. This person Will be responsible for up to 12 direct reports. Will manage and lead the development of new process validation and automation of existing processes in a highly regulated environment.
Responsible for the following:KNOWLEDGE, SKILLS AND ABILITIES:
-Previous experience performing validation and design of medical device equipment and processes
-Strong understanding of CAPA processes including IQ, OQ, PQ and Root Cause Analysis theories.
- Previous experience working within medical device field and strong understanding of ISO 13485, 21 CFR 820, ISO 11607
- Prior experience managing quality, manufacturing, and deign engineering teams
-Strong background with analytical and statistical analysis
- Experience in automating processes such as milling, machining, deburring, grinding processes
- Experience with ISO 13485 and 21CFR820 part 820
- Medical Experience
- Management Experience
Your success starts with the right career opportunity. Aerotek uses a people-focused approach to connect job seekers to incredible opportunities with leading organizations. Established in 1983, we've grown to become a consistent Best of Staffing® winner for talent satisfaction because of our dedication to exceptional service. Serving over 300,000 contract workers every year, we specialize in placing workers with engineering, scientific, professional and industrial skill sets. Aerotek is proud to offer competitive benefits, including contributory medical, dental and vision insurance, weekly pay, discounts on consumer goods and services and more.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.