R&D Engineer

Medical Engineering Consultants (MEC) supports medical device and pharmaceutical companies by providing resources, knowledge, and expertise to augment and supplement their work. Our vision is to align clients’ needs with the best resources available, creating sustainable solutions that validate processes, ensure compliant quality systems, and close gaps between current and FDA-expected stages. MEC offers short or long-term support, from high-end leaders and consultants to skilled engineering staff and subject-matter experts. Our mission is to inspire positive cultural change and exceed client expectations.

About the role

Develops new technology, products, materials, processes, or equipment with minimal supervision. Independently or as part of a team, plans, executes, and directs major segments of complex projects. Compiles and analyzes operational, test, and research data to establish technical specifications for designing or modifying products, processes, and materials.

Responsibilities

• Generates innovative and unique solutions to market needs and submits idea disclosures, resulting in new or refined products, processes, or equipment.
• Completes complex engineering work in technology development, product design, 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 the technical community.
• Designs and coordinates complex engineering tests and experiments.
• Coordinates, manages, and documents project goals and progress, recommending revisions as needed.
• Assesses feasibility and soundness of proposed engineering evaluation tests, products, or equipment.
• Interfaces with physicians and cath lab personnel to obtain feedback on concepts and performance of new devices.
• Translates customer needs into product requirements and design specifications.
• Responsible for engineering documentation.
• Works cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing teams on complex projects to ensure success.
• May train and/or provide work direction to technicians and entry-level engineers.
• Demonstrates PDP/TPD system knowledge through high-quality deliverables.

Quality Systems Duties

• Builds quality into all aspects of work by maintaining compliance with quality requirements.
• Handles CAPAs, NCEPs, SCAR investigations, and initiates/manages design changes.
• Updates engineering prints as necessary and communicates with contract manufacturers and client operations/design teams.
• Primary work involves supporting the manufacturing line for a hepatic artery infusion pump and accessories.

Requirements

• 5–8 years of experience with a BS, 3–6 years with an MS, or 0–3 years with a PhD.
• Experience with engineering prints and driving design changes in medical devices is required.
• Mechanical engineering background.
• Ability to take work direction and work independently.
• Desired: 5–8 years of medical device experience.