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Senior Mechanical Engineer, Tech Transfers

Company: Biomerics
Location: Bridgeport
Posted on: November 21, 2022

Job Description:

Job Title: Senior Mechanical Engineer, Tech TransfersCompany: Biomerics NLELocation: Monroe, CTPosition Type: Full-TimePosition Summary:Biomerics is a world-class contract manufacturer specializing in the design, development, and production of medical devices. The Biomerics NLE division provides full-service metal processing to the interventional and surgical medical device markets.The BNLE Tech Transfer team is seeking passionate Engineers at multiple levels of experience to join us in Monroe, CT. 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.Onboards 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.Qualifications:1. Bachelor's Degree in Mechanical Engineering or equivalent with 10+ years industry experience, Master's degree with 8+ years industry experience.2. Thorough understanding of medical device manufacturing, especially as it relates to FDA (cGMP) manufacturing requirements.3. Passing a background check, which may include verification of prior employment, criminal conviction, educational and driving records.

Keywords: Biomerics, Bridgeport , Senior Mechanical Engineer, Tech Transfers, Other , Bridgeport, Connecticut

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