Product Engineer/R&D Engineer at COLTENE USA

Coltene has an opening for a 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. Adherence to domestic and international regulations and local design control practices will be of critical importance for all work performed.

Duties and responsibilities

• Participate in cross-functional teams for both small and large projects. Generate new

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.

• 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.

• Create innovative solutions to existing products in the areas of quality, cost, or

functionality as needed.

• Review, analyze and approve design deviations as appropriate.

• Analyze and evaluate design activities, including the analysis of materials, stresses,

dimensions, tolerances, manufacturability, and satisfaction of design input requirements.

• Create and maintain product specifications, including 3-D CAD models of parts and

assemblies, electrical schematics, layouts, parts lists and cost estimates. Provide

direction to Engineering Services in the creation of detailed drawings and specification

documents.

• Adhere to Coltene Design Control procedures and all applicable regulatory guidelines

when working with product designs.

• 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 and/or Regulatory team members in the development of product

labeling and literature by recording, interpreting and explaining technical data and

product performance.

• Maintain documents included in a risk management file, including Hazard Analyses, Risk

Analyses, and dFMEAs.

• 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.

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 engineering or other technology field required (Mechanical

Engineering strongly preferred)

• 3-6 years of progressive experience in various engineering roles

• 2+ years of progressive experience successfully leading projects

• Familiarity with medical device standards preferred (ISO 13485, IEC 60601-1, ISO 10993,

21 CFR Part 820, etc.)

• Proficient in 2D/3D CAD design software (Autodesk Inventor preferred)

• Proficient in Microsoft Office Suite (Teams, Word, Excel, Project, Visio, Power Point,

Outlook, etc.)

• Able to provide guidance and mentoring to team members when appropriate

• Able to adapt to and adopt new technologies.

• Able to apply technical knowledge to think critically solve problems, and analyze

• Able to assess situations and make logical decisions, communicate in a timely manner

(both verbal and written) and report effectively to internal and external audiences.

• Able to manage time effectively

• Comfortable taking initiative independently

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.

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.

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

EOE STATEMENT

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