Sr. Product Engineer (Medical Device)
Company: Coltene Whaledent, Inc.
Location: Cuyahoga Falls
Posted on: May 10, 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
- 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
- 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 the organization.
- 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. Qualifications The 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
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
- Able to adapt to and adopt new technologies with ease
- Able to provide technical and programmatic guidance as needed
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 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 discretionary basis.
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
EOE STATEMENTIt 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
Keywords: Coltene Whaledent, Inc., Cuyahoga Falls , Sr. Product Engineer (Medical Device), Healthcare , Cuyahoga Falls, Ohio
Didn't find what you're looking for? Search again!