NPI Engineer - Tegra Medical

Job Summary

Seeking an experienced professional to manage projects in a contract manufacturing company that serves the medical device industry. Principally responsible for ensuring seamless prototype to production transfer, production line duplication, and maintaining some communication with the customer to meet their quality and on-time delivery expectations. The ideal candidate will be accountable for overall project implementation by working both hands on and with cross functional teams to deliver manufacturing solutions for medical device production.

Role and Responsibilities

• Effectively liaisons with Development (GTC: Genesis Tech Center), Quality, Operations, and Materials, teams to produce desired results and meet project milestones.
• Drives product serial production release based on capabilities and efficiency KPI’s, supports serial ramp up and production handover.
• Establishes regular project meetings involving Engineering, Quality Operations and Sales à Principal point of contact between customer and production team.
• Manages continuous improvement and cost reduction projects after handover to serial production.
• Supports hands on development activities related to fabrication of products.
• Supports customer requests for quote and provides input from SME during quoting.
• Responsible for recommending new technologies such as laser technology and creates criteria which technology fits best for desired part. Role will be supporting laser welding and cutting process development.
• Ensures new products are supported through internal or external resources.
• Ensures Drawings, Tooling, Work Instructions, inspection equipment and methods, and training requirements are accurate.
• Assists in the development and completion of required validation protocols, reports, and other quality activities and documentation.
• Drive and maintain multiple program schedules and report status of projects on a regular basis, including schedule updates, resource allocation, and cost tracking.
• Support the conversion of small-scale processes into commercially viable large-scale operations.
• Assume a hands-on approach to product transfer, developing processes, and establishing manufacturing cells.
• Manage validation of new processes. Monitor and improve processes for the manufacture of medical device components and assemblies.

Qualifications and Education Requirements

• A Bachelor’s degree in Engineering and at least 2+ years engineering experience in a medical device manufacturing environment is required (candidates with a wide range of experience in a similar Medical Tech position will be considered as well).
• Must have experience with Class II & Class III finished medical devices and laser technology.
• Should have experience in managing product and process developments as well as the ability to lead programs that involve the design and manufacture of medical components and devices.
• Must possess a pro-active attitude and provide leadership and project management to a cross functional team and assist in directing them in achieving assigned goals and objectives.
• Must be a self-motivated, hands-on individual and team-player with a strong sense of urgency and passion for the products.
• Must have the ability to react quickly to changing requirements and new processing developments as well as have a keen interest in quickly learning and applying new skills.
• Experience with Microsoft Project and CAD software preferred.