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Process Engineer - Stoughton, United States - Boston Orthotics & Prosthetics
Description
Job DescriptionJob Description
OrthoPediatrics Specialty Brace:
As a leader in specialized pediatric orthotics, we take great pride in having the industry's top clinicians, technicians, and administrative staff, led by an executive team dedicated to advancing the orthotics and prosthetics profession.
Our Vision:
To be recognized as the premier provider of pediatric orthotic and prosthetic services and products in the United States.
Our team believes in respectful truth and transparency when interacting with patients, referral sources, and our own team members. We hold ourselves accountable for providing only the best products and services to our patients. Our team is engaged and committed to continuous improvement of our products, our patient care, and ourselves.
GENERAL SUMMARY:
Develops and improves manufacturing processes by studying product and manufacturing methods. Evaluates manufacturing processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials.
Providing inputs to suppliers on developing manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors.
ESSENTIAL FUNCTIONS:
Full working knowledge of all supporting department needs and capabilities, including the ability to discern when inaccurate information is supplied and offer ideas for how to correct it.
Process Risk (PFMEA)
Contract review
Materials
Maintains supplier performance metrics
First Article Submissions
Deviations and Non-conformances
Validations support
CAPA/SCAR support
Packaging, labeling and product identification
Works as a (PCT) member with New Product Development providing inputs for Design for Manufacturability (DFM) and supports product launches through operational process focus and change control, including but not limited to:
BOM creation and maintenance
Material establishment.
Print reviews
Assures product and process quality by designing testing methods; testing finished- product and process capabilities; establishing standards; confirming manufacturing processes.
Maintains product and company reputation by complying with government regulations.
Must support both internal and external processes audits.
Works on both internal and external Continuous / Process improvements through methodologies such as Lean Six Sigma
Creates documentation around process standards, Standard Operating Procedures and Work Instructions.
SUPERVISORY RESPONSIBILITIES:
None
QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. (The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)
Is highly organized and has very effective time management skills.
Is highly computer literate and uses sales database tracking programs.
Problem solving skills required.
Knowledge of Lean Manufacturing, Six Sigma & quality systems is a plus.
Must have a thorough knowledge of Company products, processes, and Good Manufacturing Practices.
Must be able to communicate appropriately, written and oral forms, with all levels of management
Must have proficient writing ability when putting together professional documentation and procedures.
EDUCATION AND/
OR EXPERIENCE:
B.S.
in mechanical, industrial, or other engineering science or a Bachelor's degree in another discipline accompanied by the Certified Manufacturing Engineer certification (CMfgE) granted through the Society of Manufacturing Engineers (SME).
2-3 years of experience in manufacturing environment(orthopedics/medical
device preferred). Must have knowledge of methods and equipment; and be trained on equipment and processes in the area. Adhere to all safety standards at all times.
LANGUAGE SKILLS:
Ability to read and comprehend instructions, correspondence, and memos. Ability to prepare routine reports and correspondence. Ability to communicate effectively with customers, vendors and other employees of the organization. Requires excellent grammar and spelling.
MATHEMATICAL SKILLS:
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to Ability to add compute rate, ratio and percent.
REASONING ABILITY:
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
CERTIFICATES, LICENSES,
REGISTRATIONS:
Requires a valid driver's license.
OTHER SKILLS AND ABILITIES:
Requires the ability to operate a variety of standard office equipment, such as a computer and keyboard, calculator, fax, photocopier, telephone, cell phone, etc.
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 will be made to enable individuals with disabilities to perform the essential functions.)
While performing the duties of this job, the employee is regularly required to sit and use hands to finger, handle or feel.
Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, 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.)
The noise level in the work environment is that found in a "normal office environment; noise levels during visits to other locations in the building may be moderate and occasionally loud.
The above statement reflects the general details necessary to describe the principle functions of the occupation described and shall not be construed as a detailed description of all the work requirements that may be inherent in the occupation.
Boston O&P is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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