Manufacturing Engineer

Summary

• This position is responsible for work-center identification, process definition & documentation, set-up instructions, tool design and validation, first article production validation, product qualification / measurement instructions, and packaging instructions.

Essential Duties & Responsibilities
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Documenting all aspects of the manufacturing and qualification process for a product including identification of specific tooling, jigs, fixtures, machines, machine settings, measurement tools, techniques, environmental conditions, and data to be collected
• Establish & document processes and procedures to ensure and prove a product is produced correctly and consistently through collecting and compiling objective, measurable evidence for all applicable process / product features and key characteristics over the life of the product
• Optimize the inventory and logistics process
• BOM & Router development and maintenance and process optimization, focusing on controlling product quality, safe production methods, maximizing productivity, and elimination of waste from the production process
• Uploads and maintains GDSN & FDA GUDID information.
• Complete risk analysis and failure mode & effects analysis
• Complete process capability study and gap analysis
• Develop and replication standard work instruction documentation
• Utilize advanced manufacturing technologies on a day-to-day basis
• Incorporate Lean Six Sigma, Kaisan and 5S Leadership into daily work
• Develop and maintain BOM/Router documentation
• Establishes Unique Device Identifier
• 10% travel may be required
• Other duties as assigned

Competencies

• Communication: Effectively communicate to internal and external business partners by sharing expertise to encourage accomplishment of shared business goals.
• Teamwork and Collaboration: Actively support and collaborate with peers and team members to contribute to overall company success.
• Knowledge: Display knowledge of department, applicable products, services and business objectives. Demonstrate a continuous learning mindset through continued professional and personal development.
• Accountability: Follow through with tasks and responsibilities in an appropriate and timely manner.
• Work Quality: Produces results, meets goals, and provides services that meets or exceeds EHOBs standards.
• Adaptability: Readily and effectively adapts way of working, thinking and acting in response to changing workplace conditions, targets or goals.
• Strategic Thinking: Demonstrate ability to understand a situation or obstacle from all perspectives.
• EHOB Ambassador: Reflect EHOBs mission, vision and values.

Qualifications
Education and/or Experience

• Bachelor of Science or higher in Mechanical, Manufacturing Engineering, or Manufacturing Engineering Technology.
• Minimum of 3 years of Manufacturing Engineering experience within a regulated industry.
• Demonstrable knowledge and mastery of performing Needs Assessment and Requirements definition and evaluation.
• Demonstrated experience in Engineering Print Reading, Geometric Dimensioning and Tolerancing, mathematical manipulation and translation of dimensional information, and familiarity with Model Based Definition Interrogation.
• Excellent ability to prioritize, self-start, and work independently and within a team.

Other Skills

• Language skills: Ability to read, analyze, and interpret the most complex documents. Ability to respond effectively to the most sensitive inquiries or complaints. Ability to make effective and persuasive speeches and presentations on controversial or complex topics to top management, public group, and/or boards of directors.
• Mathematical skills: Ability to work with mathematical concepts.
• Reasoning: Ability to define problems, collect data, establish facts and draw valid conclusions. Ability to interpret an extensive variety of information.
• Computer skills: Knowledge of Microsoft Office Suite

Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and talk or hear. The employee is occasionally required to reach with hands and arms and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; risk of electrical shock; risk of radiation and vibration. The noise level in the work environment is usually moderate.

EHOB does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status or military service.