Product Engineer -Medical Devices

Company: Coltene Whaledent, Inc.
Location: Cuyahoga Falls
Posted on: April 1, 2021

Job Description:

COLTENE has an opening for a Product Engineer to join our Research and Development group at our site in Cuyahoga Falls, Ohio. The Product Engineer shall support the product portfolio, customer needs and P&L objectives of COLTENE by contributing to all phases of the product lifecycle as required. This includes conceptualization, research, development, testing, commercialization and post-launch support. 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 product designs.
• Conceptualize new product ideas or technologies which can be applied to new products. These concepts can be developed into initial designs and the coordination of activities to generate design prototypes for testing.
• Analyze and evaluate design activities, including the analysis of materials, stresses, dimensions, tolerances, manufacturability and satisfaction of design input requirements.
• Create and execute test procedures, including documentation of procedures, recording of results and generation of reports. Testing to perform verification and validation must meet regulatory guidelines.
• Assemble required documentation to transfer new product designs to production.
• Evaluate product issues and defects based on customer or manufacturing complaints. Identify root cause and develop and implement design-related corrective action plans per quality standards.
• Seek out and recommend improvements to existing products in the areas of quality, cost or functionality.
• Review, analyze and approve design deviations as appropriate.
• Create and maintain product specifications, including 3-D CAD models of parts and assemblies, electrical schematics, layouts, parts lists and cost estimates.
• Maintain project and product documentation in accordance with GMPs, FDA, ISO, MDR and other pertinent regulatory governance, including Design History Files, Technical Dossiers, User Guides and Technical Repair Manuals. Assist Marketing in the development of product labeling and literature by recording, interpreting and explaining technical data and product performance.
• Provide support for product approvals with outside agencies.
• Create documents included in a risk management file, including Hazard Analysis, dFMEA and uFMEA.
• 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.
• Communicate with internal and external manufacturers regarding product design, quality and manufacturing-related issues.
• Complete special projects as required by the Research & Development Manager.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. QualificationsThe minimum qualifications listed below are representative of the knowledge, skill and/or ability needed in order to successfully perform the job.
  • Bachelor's degree in engineering or other technology field required
  • 1-3+ years of progressive experience in manufacturing and/or engineering
  • Appropriate combination of education and experience may also be acceptable
  • Proficient in 2D/3D CAD design software (Autodesk inventor preferred)
  • Proficient in Microsoft Office Suite (Word, Excel, Project, Visio, Power Point, Outlook)
  • Ability to problem solve and analyze
  • 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
    BenefitsColtene 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

Keywords: Coltene Whaledent, Inc., Cuyahoga Falls , Product Engineer -Medical Devices, Engineering , Cuyahoga Falls, Ohio