NPI Development Engineer

At Tegra Medical, our employees manufacture "medical instruments that come to life". If you would like to be part of a great team and a culture built on, "Partnership and Commitment" look no further. We are hiring Located in Dartmouth, MA., we offer competitive wages and great benefits.

Job Summary:

The position will support the integration of new products into production by defining and developing manufacturing processes and helping to manage projects through the transfer to manufacturing. This position is ideal for an ambitious individual who embraces opportunities for growth and thrives in a fast-paced environment. Must have medical device experience.

Role and Responsibilities:

• Effectively liaisons with GTC, Quality, Operations, and Materials teams to produce desired results and meet project milestones
• Drives product serial production release based on capabilities and efficiency KPIs, supports serial ramp up and production handover
• Establishes regular project meetings involving Customers, Engineering, Quality, Operations and Sales
• Manages continuous improvement and cost reduction projects after handover to serial production
• Supports hands on development activities related to fabrication and assembly of products.
• Supports customer requests for quote and provides input from SME during quoting phase
• Responsible for recommending new technologies and equipment to support new product lines
• 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.
• Reads blueprints, sketches, GD&T, and computer-aided design (CAD)
• Trains employees on manufacturing processes
• Compliance to Good Manufacturing Practices (GMP) and all documented procedures in the Tegra Medical Quality Management System.

• B.S. in Engineering or equivalent experience
• Strong problem-solving and leadership skills
• Ability to work well in a fast-paced environment
• Highly autonomous; ability to work independently
• Demonstrated ability to communicate effectively
• Capable of using measurement tools such as micrometers, gauges, indicators, and related quality tools
• Experience with grinding and/or other machining processes
• Should have good written and oral communication and interpersonal skills and be able to be flexible in a dynamic, fast paced environment.
• Experience in an ISO13485 or FDA Regulated facility is preferred.
• Excellent organizational skills with a commitment to meeting deadlines and expectations while ensuring overall quality is required.
• Should have previous experience with customer communications.
• Knowledge and experience with ERP/MRP systems, preferably SAP
• Be proficient with Microsoft Office.
• Strong decision-making capabilities and the capacity to handle confidential information is required.