Engineer - Degreed IV - Electrical Engineer

OLSA Resources, Inc.; California (MO); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading engineering consultancy is seeking an experienced Electrical Engineer to design and maintain electronic components for medical devices. Responsibilities include managing quality systems, leading technical projects, and ensuring compliance with FDA and international regulations. The ideal candidate will have a Bachelor's degree in Electrical Engineering and at least five years of relevant experience. This is a vital role in a collaborative environment, working with multiple engineering disciplines within a commitment to innovation.

Qualifications

• Minimum of five years relevant work experience in electrical engineering.
• Knowledge of FDA and international regulations affecting medical devices preferred.

Responsibilities

• Implement and maintain the effectiveness of the quality system.
• Design electrical and electronic components for medical devices.
• Supervise the generation of engineering change documentation.

Skills

Electrical Engineering principles

Problem solving

Technical project management

Education

Bachelor’s degree in Electrical Engineering or closely related discipline

Job description

• Contract

Company Description

Job Description

Primary Function:

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

Designs electrical and electronic components, assemblies and systems (PCBAs, instrumentation, signal processing, control systems, power distribution systems, cables, etc) for use in Medical Devices

Revises existing designs to resolve issues associated with component obsolescence, EOL, manufacturability, or product performance.

Works with Operations, Supplier Quality, and external suppliers to develop, evaluate and release new designs for fit with manufacturing methodologies and requirements (DFM).

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 drawings 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 Electrical 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.

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.

Additional Information

Job Location