Senior Research And Development Engineer

• This is a Senior Tech-Lead role within the R&D department at Microline Surgical, and provides leadership for cross-functional teams to design and develop new products that drive down manufacturing cost and lead times, and meet market needs.
• Responsible for developing technology & component strategies for new products, while also identifying opportunities to improve existing products.
• Responsible for developing new technology, products, materials, processes, or equipment with minimal supervision. Independently, or as a member of a team, develops, directs, and executes plans for a major segment of complex projects.

The incumbent may be required to perform all or a combination of the following essential functions as determined by business necessity.

• Translates customer needs into product requirements and design specifications.
• Consistently generates innovative and unique solutions to market needs and submits idea disclosures resulting in the development of new or refined products, processes or equipment.
• Interfaces with Physicians to obtain feedback on concepts and performance of new devices.
• Works cooperatively with marketing, quality, manufacturing, regulatory and other functions on complex projects to ensure successful New Products to be developed.
• Coordinates, manages, and documents project goals and progress of an R&D team and recommends appropriate actions.
• Assesses the feasibility and soundness of proposed products, engineering evaluation tests, and equipment.
• Responsible for engineering documentation, especially Design History File (DHF).
• Successfully completes complex engineering work and documentation in one or more of the following: technology development, product design and development, test of materials or products, preparation of specifications, process study, research investigation (animal and clinical studies), and report preparation.
• Selects techniques to solve complex problems and makes sound design recommendations.
• Summarizes, analyzes, and draws conclusions from complex test results.
• Designs and prepares complex reports to communicate results to technical community.
• Designs and coordinates complex engineering tests and experiments

• Researches and analyzes information such as customer requirements, standards, and industry trends to determine feasibility of design or application.
• Interface with health care professionals on product requirements.
• Designs, develops, analyzes and documents product designs in accordance with ISO, FDA and corporate design control guidelines
• Coordinate and lead a cross-functional team from prototype stage through pilot manufacturing including manufacturing process validation.
• Knowledgeable in state of the art manufacturing processes (plastics, 3-D printing, etc)
• Perform and report on evaluation testing, verification and validation in accordance with ISO, FDA and company design control guidelines.
• Knowledgeable on design for reliability
• Accurately predict the time required for project tasks; help assure the scheduled time is met or improved to meet company objectives.

• Serves as the project team leader throughout the New Product Development process, identifies critical technical challenges, defines schedules, assigns tasks and quantifies progress against project goals.
• Effectively communicate information to peers, customers and suppliers in order to facilitate project goals.
• Serve as a mentor to other engineers in the company, helping them to develop their design, analysis and problem-solving skills
• Represent the company and R&D department on Microline Surgical’s behalf in technical conferences, committees and meetings with medical professionals, technologists, attorneys, etc.

• Utilize company design control procedures and project management techniques to effectively drive development of new, high-quality devices, or product improvements.
• Adhere to all company policies, rules, procedures and housekeeping standards

In addition to the essential functions listed above, the incumbent may be required to perform other non-essential functions.

Employees are required to…