SUMMARY

The Manufacturing Engineer will serve as a valuable member of the Manufacturing and Engineering teams for building pre-production and test devices, evaluating device costs, planning and executing process validations, identifying suppliers, and ensuring design for manufacturability of all products. This position will play a key role in assisting production for products experiencing high growth rates under tight deadlines.

PRIMARY RESPONSIBILITIES

Manufacturing Engineer

• Support cost improvements including performing detailed cost analysis and compliance impact.
• Support resolving manufacturing issues (NCMR and CAPA support).
• Generate and maintain manufacturing specifications, production BOMs, drawings, inspection plans, labeling, and other product documents.
• Generate and maintain BOMs and routings in ERP system.
• Evaluate product flow and propose process improvements to maximize efficiencies in new and established manufacturing processes.
• Support the transfer of new products and product changes to production (pilot and full-scale).
• Monitor and react to trends in key process parameters (i.e. yield, output, throughput, and capacity) to improve production results.
• Assist with day-to-day operations including vendor identification, quoting, purchasing, receiving, inventory management, and supplier management.
• Provide engineering and technical support to operations, engineering, and quality teams.

Process development and validation

• Support the design and development of manufacturing processes for new products, product changes and enhancements, and related tooling and fixtures.
• Review manufacturing process validation activities.
• Utilize Lean Six Sigma (LSS) tools and concepts to assist in process improvements.

New product development support

• Partner with Product Development staff to ensure that products under development are designed for manufacture.
• Support Process Failure Modes and Effects Analyses (pFMEAs).
• Prepare estimates of time and cost for production qualification and production transfer projects.
• Lead and participate in the design and development of manufacturing processes for new products, product changes and enhancements, and related tooling and fixtures.
• Utilize costed BOMs, timed pilot builds and scheduling to establish cost of goods sold (COGS).
• Generate manufacturing specifications, production BOMs, drawings, inspection plans, labeling, and other product documents.
• Plan and lead prototype and pilot production of new products, design changes, and enhancements.

KNOWLEDGE AND SKILL REQUIREMENTS

• Bachelor’s Degree in Manufacturing Engineering or related field.
• Minimum 0-4 years of experience with FDA/GMP regulated medical device manufacturing.
• Project management including planning, execution, and meeting time and budget constraints.
• Understanding of medical device DHF, DMR, and DHR files management and documentation requirements.
• Experience developing and executing IQ, OQ and PQ product and process validation activities.
• Excellent organizational, interpersonal, oral and written communications skills.
• Proficiency in MS Word, Excel, Visio, MS Project and PowerPoint

WORKING CONDITIONS

• Small office environment, electrical and mechanical prototyping labs.
• Ability to “get the job done” in a we-can-do environment, allowing for flexible hours, depending upon the project and/or customer needs.
• Periodic travel, such as supplier visits, can usually be planned well in advance.