Product Engineer -Medical Devices
Company: Coltene Whaledent, Inc.
Location: Cuyahoga Falls
Posted on: April 1, 2021
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
- 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
- Assemble required documentation to transfer new product designs
- 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
- Seek out and recommend improvements to existing products in the
areas of quality, cost or functionality.
- Review, analyze and approve design deviations as
- 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
- 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
- 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
- Bachelor's degree in engineering or other technology field
- 1-3+ years of progressive experience in manufacturing and/or
- Appropriate combination of education and experience may also be
- Proficient in 2D/3D CAD design software (Autodesk inventor
- 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
- 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
Keywords: Coltene Whaledent, Inc., Cuyahoga Falls , Product Engineer -Medical Devices, Engineering , Cuyahoga Falls, Ohio
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