Medical Device Electrical Engineer

About the role

The ideal candidate will be comfortable with sustaining activities (projects) which they are currently responsible for verses new designs. Looking for an engineer that can approach a problem with no obvious root cause and with limited design history to help figure out what's going on, must like a challenge. The ideal candidate will come off a bit fearless, prefer if they can write their own F/W code when needed, can take undocumented designs and completely reverse engineer them and then redesign them so they work for them, would like some exp with hands-on electromechanical control systems.

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.

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.

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.
• Additional Information: M-F 8am to 5pm