Engineer , Sustaining, R&D

Engineer 2, Sustaining, R&D

Under general direction, the Sustaining R&D Engineer, based in Morrisville NC, is responsible for the sustaining engineering projects of Anesthesia and Emergency medicine products. Experience and background requirements should focus on disposable medical device products. This position has PTG (Product Technology Group) responsibility, including organizing and managing multiple projects and ensuring they are completed in a timely manner. Assignments will primarily be focused on existing products within the portfolio, providing creative solutions to technical issues or modifying/improving the product as required.

The candidate must be capable of advanced level scope of assignments in planning, designing, and coordinating the development and implementation of related engineering activities to support changes and improvements to existing products lines, and implement successfully into manufacturing. Incumbent at this level self-manages their project work, seeks help when required, and is fully aware of the operating procedures and policies of the work unit.

Principal Responsibilities:

• Acts as product technology group owner/subject matter expert for assigned product lines.
• Coordinates the product design and development process with appropriate support departments such as engineering, quality, regulatory, marketing, documentation, operations, procurement.
• Serve as an R&D technical lead representative in transfer, integration, or other corporate initiative core teams. Collaborate with Engineering, Quality, and Regulatory to understand technical targets and design control systems.
• Serves as project leader for assigned projects; responsible to follow up on all aspects of projects. Reports project statuses and key metrics and dashboard updates to required systems.
• Resolves complex process/product development and manufacturing issues; independently takes lead of working cross functional teams.
• Prepares formal documentation of the product designs, change management, risk analysis, product requirements and specifications, customer needs, etc. according to established product development procedures. Initiates formal reviews to progress projects to compliant completion.
• Prepares or coordinates development of design drawings, specifications, estimates of costs, documentation updates, etc. Utilizes appropriate PLM, ERP and other product-related database systems.
• Conducts research on projects associated with the design and/or design modifications of medical devices, components, models, or mechanisms.
• Develops, maintains, and publishes plans for assigned projects with critical milestones and timelines. Owns the change management activities for sustaining or supplier-initiated changes. Leads design transfer activities when required.
• Develops and coordinates the execution of protocols for validations of new or modified devices or components, including validations of the design, test methods, manufacturing processes, assembly, packaging, and sterilization where applicable.
• Primary R&D interface with operations for cost improvement projects, vendor materials, and finished goods qualifications.
• Investigate and resolve technical production problems involving product performance.
• International efforts (travel, interface) are key, as role supports new product development and sustaining engineering efforts for the manufacturing plants as applicable.
• Consults with sales staff or customer on product requirements where design or manufacturing issues or changes are involved.
• Demonstrates professional responsibilities by cooperating with other personnel to achieve department objectives and maintain good employee relations, interdepartmental objectives, and departmental goals and objectives.

Education / Experience Requirements:

• Bachelor's Degree in Engineering
• Minimum 3-5 years of work experience in the development of devices within the medical device industry. Prior work in testing, validation and/or sustaining engineering is preferred, with close partnerships with manufacturing teams.
• Experience in Solid Works CADD (design/drafting) program preferred
• Microsoft Office Suite (Project, Word, Excel) required
• Injection molding, plastic extrusion, plastic part assembly, wound care, hemostatic product experience a plus
• Experience working within the medical device-related industry requirements (FDA, MDD, MDR, ISO Standards, etc)
• Relational database experience (such as Oracle Agile) and ERP experience (SAP, Oracle) a plus
• Testing experience using ISO and ASTM testing methods for medical devices and general plastic components preferred
• Principles and practices of professional engineering
• Regulations pertaining to medical device design and design modifications

Specialized Skills / Other Requirements:

• Strong written and verbal communication skills and attention to detail.
• Effectively present information and respond to questions from groups of customers, peers, managers, senior leadership.
• Solve practical problems and deal with a variety of concrete…