Sr. Product Engineer (Medical Device)
Company: Coltene Whaledent, Inc.
Location: Cuyahoga Falls
Posted on: May 11, 2022
Coltene has an opening for an experienced Product Engineer to
join our R&D team at our Cuyahoga Falls, OH location. 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. This role
allows for a hybrid schedule (3 days onsite, 2 days remote) after
the training is completed.
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.
Participate in cross-functional teams for both small and large
projects. Roles assumed may be leading, contributing to, or
supporting the various projects. Required contributions may include
documentation of project plans and schedules, task performance and
creating meeting minutes as well as facilitating team communication
and presentations at management review meetings.
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.
Assemble required documentation to transfer new product designs to
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 appropriate.
Create and maintain product specifications, including 3-D CAD
models of parts and assemblies, electrical schematics, layouts,
parts lists and cost estimates. Direct Engineering Services in the
creation of detailed drawings and specification documents.
Maintain project and product documentation in accordance with GMPs,
FDA, ISO, MDR and other pertinent regulatory governance, including
Design History Files, Technical Documentation, 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.
Initiate and coordinate product approvals with outside
Create documents included in a risk management file, including
Hazard Analysis, dFMEA and uFMEA.
Communicate with internal and external manufacturers regarding
product design, quality and manufacturing-related issues.
Align with product management to define and maintain cost targets,
develop business plans, and meet the overall business objectives of
Complete special projects as required by the Research & Development
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.
The 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
(Electrical, Mechanical, or Biomedical preferred)
5-8 years of progressive experience in various engineering roles;
Project management experience highly preferred
Appropriate combination of education and experience may also be
Proficient in 2D/3D CAD design software (Autodesk Inventor
Proficient in Microsoft Office Suite (Teams, Word, Excel, Project,
Visio, Power Point, Outlook, etc.)
Familiarity with medical device standards preferred (ISO 13485, IEC
60601-1, ISO 10993, 21 CFR Part 820, etc.)
Ability to think critically, problem solve, and analyze
Technical capacity including decision making, communication (both
verbal and written) and reporting effectively to internal and
Timely and effective responses to inquiries and requests
Works under general supervision with the expectation of a wide
range of creativity and latitude
Experience in Design for Manufacture including injection molding,
machining, assembly, and electrical component fabrication.
Able to adapt to and adopt new technologies with ease
Able to provide technical and programmatic guidance as needed
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 Research & Development
Manager. Special circumstances such as off shift and weekend work
might occur on rare occasions. This position requires minimal
travel. Potential for remote/hybrid work arrangement exists on a
Coltene offers a comprehensive employee benefit program that
enables our employees to stay healthy, feel secure and maintain a
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
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
Keywords: Coltene Whaledent, Inc., Cuyahoga Falls , Sr. Product Engineer (Medical Device), Healthcare , Cuyahoga Falls, Ohio
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