Senior R&D Engineer

Summary

• 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.

Essential Functions

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

Responsibilities

• 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

New Product Development

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

Communication and Leadership

1. 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.
2. Effectively communicate information to peers, customers and suppliers in order to facilitate project goals.
3. Serve as a mentor to other engineers in the company, helping them to develop their design, analysis and problem-solving skills
4. Represent the company and R&D department on Microline Surgical’s behalf in technical conferences, committees and meetings with medical professionals, technologists, attorneys, etc.

Quality

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

Non-Essential Functions:

In addition to the essential functions listed above, the incumbent may be required to perform other non-essential functions. Employees are required to follow any other job-related instructions and to perform any other job related duties requested by their supervisor.

Qualifications

Minimum Qualifications:

• BS or MS in scientific / technical discipline such as Mechanical, Biomedical Engineering
• Minimum 6-10 years of related experience in the medical device industry developing Class II Medical devices
• Minimum 3 years of Technical Management or Project Leadership experience
• Must have demonstrated knowledge of regulations and standards effecting medical product development.
• Experience translating customer needs to product requirements; and developing DHF deliverables like Product-spec, Risk Management, Verification & Validation, etc.
• Strong ability to interact and collaborate with physicians in the field, preclinical studies, with hands-on capability in the lab
• Knowledge of ISO, FDA, GMP and design control process is required
• Knowledge of IEC standards and testing.
• MEs must be proficient in Solidworks.
• Demonstrated knowledge of Product Design for Assembly (DFA).

Preferred Qualifications:

• Experience as project Team Leader
• Experience developing Electro-Mechanical Products for Minimally invasive surgery
• Demonstrated technical decision making
• Proven success with delivering Manufacturable concepts to Production and launch into market
• Effective communication skills required due to support of cross functional projects within a team

REASONABLE ACCOMMODATION: Microline Surgical is committed to the spirit and letter of the Americans with Disabilities Act and, as required by law, will reasonably accommodate otherwise qualified individuals.

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