Engineer - Degreed IV - Firmware Engineer

OLSA Resources, Inc.; Santa Clara (CA); Vor Ort; USD 80.000 - 100.000; Vollzeit

Zusammenfassung

A leading medical technology firm in Missouri seeks an experienced engineer to develop and maintain firmware systems for medical devices. The role involves collaborating with various engineering disciplines, ensuring compliance with FDA regulations, and guiding junior engineers. Required qualifications include a Bachelor's degree in Software Engineering and at least 5 years of relevant experience in firmware development and medical device standards. This position offers a competitive salary and benefits.

Qualifikationen

• 5 years of relevant work experience required or 8 years without a degree.
• Experience in Assembly preferred.
• Knowledge of medical device regulations preferred.

Aufgaben

• Implement and maintain the quality system's effectiveness.
• Design and develop firmware for medical devices.
• Revise firmware to address obsolescence and performance issues.

Kenntnisse

C

C++

FDA regulations knowledge

Problem-solving

Ausbildung

Bachelor’s degree in Software Engineering or related field

Jobbeschreibung

• Contract

Primary Function:

Responsible for implementing and maintaining the effectiveness of the quality system.

Designs and Develops firmware systems (interfacing with and/or controlling PCBAs, instrumentation, analog and digital signal processing, control systems, power distribution systems, etc) for use in Medical Devices.

Revises existing firmware systems to resolve issues associated with component obsolescence and/or product performance.

Works with Electrical Engineering, Software Engineering, Operations, Supplier Quality, and external suppliers to develop, evaluate and release new designs for integration into an existing product portfolio.

Generates the requirements for, and supervises the implementation of, verification and/or validation studies associated with product designs, assembly and/or test fixtures, and/or manufacturing processes.

Generates and/or supervises the generation of engineering change documentation associated with product designs, assembly and/or test fixtures, and/or manufacturing processes.

Performs assignments of a very complicated or difficult nature.

Expertise and Problem Solving Responsibilities

Performs assignments of a very complicated or difficult nature requiring a high degree of technical competence.

Plans, organizes, and conducts technical projects. Consolidates results of design elements of major projects for purpose of design review.

Uses engineering principles to conduct technical investigations involved with the modification of material, component, or process specifications and requirements.

Conceives and plans projects to explore product or process problems; defines and selects new concepts and approaches to the design or development of new or improved products or processes

Applies the results of reviews of literature, patents, and current practices to the solution of current problems. Forms and suggests ideas to support the strategic technical direction of the area

Level of Accountability

Receives general direction; exercises considerable discretion as to personal work details as well as the work details of other technical personnel.

Review project progress and evaluate results.

Reviews, generates, and approves related inputs such as documents and specifications.

Evaluates vendor capabilities to provide required products or services

Leadership Activities

Provide technical guidance to less experienced engineers, designers, and technicians.

Formulates detailed plans for execution by other less experienced engineers.

Interpersonal Skills

Interface with Manufacturing Engineering, Manufacturing and Test personnel, R&D Engineering, Quality and Regulatory specialists, Purchasing/Planning personnel, Supplier Quality organization, and external suppliers.

Qualifications

Minimum Education and Experience

Bachelor’s degree in Software Engineering or closely related discipline with at least five years relevant work experience is required. Candidates with at least 8 years relevant experience may be considered in lieu of the Bachelor’s degree. Experience with Assembly, C, C++ preferred.

Knowledge of FDA and/or international regulations and standards affecting Medical Devices and Biologics preferred. Experience with government and/or third party regulatory agencies (DOD, FAA, IEC, UL, SEMI, ISO, etc.) will be considered in lieu of medical regulatory experience.