Mechanical Engineer II, Technology Transfer (Medical Devices)

Company: Biomerics
Location: Athens
Posted on: September 23, 2022

Job Description:

Description:Position Summary:Founded in 1993, Biomerics is a mid-market medical device contract manufacturer serving the Interventional Cardiovascular, Gastrointestinal, and Advanced Surgical markets. As a vertically integrated partner, Biomerics supplies 20 of the top 30 medical device OEMs. Biomerics provides engineering development services, technical transfer manufacturing services, and contract manufacturing services for finished medical devices through various locations in the United States and Costa Rica. Biomerics is a leader in biomaterials, injection molding, extrusion, micro metals processing, medical balloons, catheter assembly, and finished packaging. Biomerics operates under a certified ISO 13485:2016 quality system and is FDA-registered.The FMI Tech Transfer team is seeking passionate Engineers at multiple levels of experience to join us in Athens, Texas. Are you: excited to create medical products for our wide range of customers, comfortable in a fast-paced environment, and proud that your efforts ultimately lead to improved quality of life for patients? If so, we would love to meet you.The right candidates will be passionate about taking critical medical devices and components from the design stage through full production. The Tech Transfer Engineers are responsible for onboarding our customers' manufacturing processes, as well as bridging the gap between Product Development and Manufacturing Engineering. Typical responsibilities include Process Development, Process Validation, Risk Management, and Design for Manufacturing. The right candidates will function as very active members of a high-performing team.Responsibilities:Designs, pilots, and develops manufacturing processes.Represents manufacturing on new product development teams.Onboarding production lines from customer sites to internal sites.Defines, identifies, and procures new equipment for manufacturing processes.Trains operators and staff on production procedures.Creates test protocols, runs experiments, and writes test reports.Completes product documentation.Analyzes complex engineering problems, defines them, and recommends and implements solutions.Leads projects with respect to timelines, budgets, and customer interactions.Skills:Works collaboratively yet independently in a team environment.Analyzes and solves problems.Knowledge of process validation, design for manufacturing, statistics, and lean manufacturing principles.Experience with root cause analysis and corrective/preventive action procedures.Proficient in interacting with all functions within a business.Knowledge of 3D modeling software, especially SolidWorks.Communicates well.Interacts with customers.Effectively presents technical materials to non-technical people.Knowledgeable of and works within FDA, MDR, ISO, IEC 60601, and other relevant regulations and standards.Requirements: Qualifications:Bachelor's Degree in Mechanical Engineering or equivalent with 5+ years industry experienceThorough understanding of medical device manufacturing, especially as it relates to FDA (cGMP) manufacturing requirements.Passing a background check, which may include verification of prior employment, criminal conviction, educational and driving records.Bilingual in Spanish is a plus!Benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, 401k with match

Keywords: Biomerics, Tyler , Mechanical Engineer II, Technology Transfer (Medical Devices), IT / Software / Systems , Athens, Texas