Manufacturing Engineer

Manufacturing Engineer at Sage Product Development, Inc.

Sage Product Development, Inc. provides fast, efficient and creative product development and low to mid volume production services to medical device companies. We are a focused team of experienced medical device engineers who know what it takes to develop successful products for startups, multinational companies, and everyone in between. We combine a high level of experience with a low overhead company structure.

We solve client companies’ technical challenges and meet their product development needs in a timely, efficient and highly personalized manner. We offer the right candidate the opportunity to work in an entrepreneurial environment, enhance their manufacturing engineering abilities, and build their network within the industry.

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off

• Perform a range of manufacturing engineering tasks on client company projects.
• Meet or exceed customer expectations.

• Lead projects to manufacture medical devices. Direct the work of manufacturing technicians.
• Participate in Material Review Board activities. Contribute to decisions regarding product and material discrepancies and actions to prevent subsequent problems or discrepancies.
• Perform all work in an organized, orderly, safe, compliant (ISO 13485:2016, 21 CFR 820) and controlled manner.
• Assist the Production Manager in scheduling production work to meet client companies’ needs, prevent bottlenecks, ensure orderly workflow and maximize efficiency.
• Ensure that all manufacturing documentation is thorough, complete, and properly stored and controlled.
• Identify resources required to complete manufacturing jobs.
• Complete IQ/OQ/PQ activities as required.
• Identify, specify and procure manufacturing equipment as required to meet production needs.
• Assist the Production Manager in performing materials management functions, including supplier management, supplier qualification, materials ordering, materials processing and inventory management.
• Provide manufacturing engineering expertise to product development projects. Contribute to the product development process by utilizing Design for Manufacturing, Design for Assembly, 5S, lean engineering, six sigma, or other methodologies.
• Generate and maintain Process FMEAs.
• Contribute to the design of tools, fixtures and processes for device assembly.
• Generate assembly procedures and routings.
• Generate labels and label artwork using Bartender, Code Soft software and Zebra printer platforms.
• Provide estimates of manufacturing costs to support the proposals.
• Design and implement new methodologies, materials, machines, processes or products as required to achieve manufacturing goals.

• Interact with client companies and Sage team members in a professional and courteous manner. Proactively communicate with client companies to ensure an ongoing two-way exchange of information.
• Prepare daily timesheets and submit completed timesheets on a weekly basis.
• Prepare documentation release and change packages for production documentation. Approve Document Change Orders (DCOs) and obtain approvals from others as required.
• Ensure that all work satisfies the requirements of Sage’s or the client companies’ Quality Systems.
• Some local travel (by car). Occasional long-distance travel (by plane).

• Any other duties as assigned.

• Provide professional, reliable and prompt service to client companies and coworkers. Work in partnership with others to meet or exceed customer expectations. Interpret customers’ needs and take appropriate action. Follow through on customers’ inquiries in a professional and timely manner.

• Work in an organized and time effective manner. Proactively seek out relevant reference materials as necessary. Take initiative for self-development. Prioritize tasks effectively. Demonstrate initiative and innovation in the use of available resources.

• Write and speak in a concise, technically accurate, timely, and professional manner. Exhibit strong…