Senior Manufacturing Engineer

Summary

Join MicroTransponder Inc. and contribute to the development and manufacturing of innovative medical devices, specifically the Vivistim® System for stroke survivors. This role involves collaborating with contract manufacturers, overseeing validation plans, and ensuring adherence to regulations. Responsibilities include managing product development, process validation, and technical support. You will develop manufacturing procedures, provide technical expertise, and participate in design assurance activities. The position requires strong technical skills, experience in medical device manufacturing, and proficiency in various software applications. MicroTransponder offers a comprehensive benefits package.

Requirements

• Bachelor’s Degree and 5+ years of relevant experience in a related discipline required
• Experience in engineering roles within the medical device industry is required
• Experience in medical device manufacturing and vendor management required
• Proficiency with computer operations, including Microsoft Office Suite (Word, Excel, PowerPoint, etc.)
• Competency with Minitab and/or other statistical software
• Competency with Smartsheet or other project management tools
• Competency with Solidworks

Responsibilities

• Oversee and technically support contract manufacturers to ensure product availability and business continuity
• Manage and execute continuation activities for internal and contract manufacturer changes as an individual contributor
• Manage and/or participate in product manufacturing and process validation technical support, including creating and managing Master Validation Plans
• Develop manufacturing procedures, manufacturing travelers, and manufacturing controls in-house and in collaboration with contract manufacturers
• Provide direction and manage contract manufacturers on manufacturing-related commercial production and product development projects
• Provide technical expertise as required in new process development, test method validations (TMV), process characterization and analysis, and process validation (installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ)) activities
• Manage and/or participate in Design Assurance activities such as risk assessment, FMEAs, such as Process FMEA (PFMEA)
• Develop and/or advise on manufacturing processes that are applicable to statistical process control, and develop those techniques
• Oversee the development of new processes, technologies, or tooling needed to manufacture the company’s products
• Provide guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques
• Prepare technical reports by collecting, analyzing, and summarizing information and trends

Preferred Qualifications

Continuous improvement methodology experience, such as Six Sigma, Lean Manufacturing, DMAIC, etc

Benefits

• Medical, dental and vision plans along with an FSA
• Company 401(k) plan with company matching
• Unlimited Paid Time Off (PTO) program
• Approximately 15 paid company holidays per year