Engineer - Degreed IV - Mechanical Engineer

• Contract

Primary Function:

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

Designs metal and plastic mechanical components, assemblies and systems (frames, skins, brackets, panels, small mechanisms, fluidics components and systems, machined and injection molded components, 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/or implements 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 product and department.

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.

Minimum

Education and Experience:

Bachelor’s degree in Mechanical Engineering or closely related discipline with at least five years of relevant experience is required. Candidates with at least 8 years relevant experience may be considered in lieu of the Bachelor’s degree. Experience with Solid Works 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.