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Manufacturing Engineer

2 months ago

Cuyahoga Falls, United States COLTENE USA Full time

COLTENE has an opening for a Manufacturing Engineer at our site in Cuyahoga Falls, OH.


The Manufacturing Engineer shall support the manufacturing operations, customer needs and the profit/loss objectives of Coltene by contributing to the development, maintenance and improvement of manufacturing processes as required. This includes machine selection and installation, process design and optimization, cost estimation, fixture procurement and software maintenance.Adherence to domestic and international regulations and local design control practices will be of critical importance for all work performed.


Duties and responsibilities


  • Adhere to Coltene Design Control procedures and all applicable regulatory guidelines when working with processes that manufacture medical device products.
  • Execute manufacturing process design and development, including machine selection and location, required fixtures, tooling and software development.
  • Develop, implement, and maintain CNC, PLC, and Robot programs for manufacturing processes, ensuring efficient and reliable operation of equipment.
  • Develop /maintain process documentation, including standard operating procedures, manufacturing work instructions, routings, and department layouts (2D CAD).
  • Participate in cross-functional teams to identify and implement process improvements, cost reduction initiatives, and quality enhancements.
  • Collaborate with production personnel to ensure effective transfer of new products and processes into production.
  • Create and maintain tooling and fixture specifications, including 3D CAD models of tools and fixtures along with related procurement and installation of such tools and fixtures.
  • Estimate cycle times, labor requirements and process costs through the use of time studies or other data-driven estimation techniques.
  • Coordinate validation and pre-production runs for new product releases.
  • Define and maintain critical control parameters for Statistical Process Control processes.
  • Review, analyze and approve process deviations as appropriate.
  • Develop, coordinate and implement technical training for employees in operations.
  • Evaluate product issues and defects based on customer or manufacturing complaints.
  • Identify root cause, develop and implement process-related correction action plans per Coltene quality standards.
  • Seek out and recommend improvements to existing processes for quality, cost or functionality.
  • Assist Product Engineers on design-related issues or when process changes affect submissions and approvals by regulatory agencies.
  • Maintain project, product and process documentation in accordance with GMPs, FDA, ISO, MDD and other pertinent regulatory governance, including the creation, execution and appropriate documentation of test procedures for Installation Qualification and Operational Qualification of manufacturing equipment.
  • Create documents included in a risk management file, including Hazard Analysis and pFMEA.
  • Participate in cross-functional teams for both small and large projects. Required contributions may include documentation of project plans and schedules, task performance and meeting minutes as well as team communication and presentations at review meetings.
  • Complete special projects as required by the Management.


Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.


Qualifications


The minimum qualifications listed below are representative of the knowledge, skill and/or ability needed to successfully perform the job.


  • Bachelor’s degree in mechanical engineering or related field, or equivalent combination of education and experience.
  • 3-5 years of progressive experience in manufacturing and/or engineering, with a focus on CNC, PLC, and Robot Programming.
  • Proficient in 2D/3D CAD design software (Autodesk inventor preferred)
  • Experience with ISO 13485 or similar quality management systems preferred.
  • Proficient in Microsoft Office Suite (Word, Excel, Project, Visio, Power Point, Outlook)
  • Ability to read and interpret blueprints, GD&T and engineering drawings.
  • Strong analytical, problem-solving, and project management skills. Basic shop math at a minimum.
  • Technical capacity including decision making, communication (both verbal and written) and reporting effectively internally and externally.
  • Timely and effective responses to common inquires.
  • Works under general supervision with the expectation of a wide range of creativity and latitude. Ability to work independently and as part of a team.


Working conditions


While performing the duties of this job, the employee works in both an office and plant environment. While in the plant, the employee regularly works near moving mechanical parts. The noise level in the work environment is quiet to moderate. This is a full-time exempt position requiring at least 40 hours per week, with hours of work and days scheduled determined by the Manufacturing Engineer Manager. Special circumstances such as off shift and weekend work might occur on rare occasions.This position requires minimal travel.


Physical and non-physical requirements


While performing the duties of this job, the employee spends time sitting at a desk, however the employee is frequently required to stand for periods of time and work out in the manufacturing area on projects.Prolonged periods of concentration and focus are required along with adequate interpersonal skills and the ability to deal with stress of time constraints. The employee is occasionally required to use hands and fingers to handle, or feel objects, tools or controls; reach with hands and arms; and talk or hear. The employee must occasionally lift and/or move up to 50 pounds. This position requires regular and consistent attendance at the facility.


Direct reports

None


Benefits

Coltene offers a comprehensive employee benefit program that enables our employees to stay healthy, feel secure and maintain a work/life balance:


Generous Paid Time Off | Holiday Pay | Medical/Prescription Insurance | Dental Insurance | Vision Insurance | Health Savings Account (HSA) | Company-Paid Life and AD+D Insurance | Company-Paid Long-term and Short-term Disability | Voluntary Life Insurance | Voluntary Critical Illness, Hospital and Accidental Injury Insurance | 401(k) | Tuition Reimbursement Program | Pet Insurance | LinkedIn Learning subscription | Volunteer Time Off | Wellness Reimbursement


It is the policy of Coltene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.In addition, Coltene will provide reasonable accommodations for qualified individuals with disabilities.