Sr. Product Engineer (Medical Device)

Company: Coltene Whaledent, Inc.
Location: Cuyahoga Falls
Posted on: May 11, 2022

Job Description:

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 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. 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 agencies.
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 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 acceptable
Proficient in 2D/3D CAD design software (Autodesk Inventor preferred)
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 external audiences.
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

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 Reimbursement Program

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

Keywords: Coltene Whaledent, Inc., Cuyahoga Falls , Sr. Product Engineer (Medical Device), Healthcare , Cuyahoga Falls, Ohio