The Associate Product Engineer is responsible for assisting with all aspects of design and development for medical devices at DENTALIS in conformance with corporate procedures and FDA Quality System Regulations. These duties include maintaining medical device designs and prototypes, detailed specifications, design for manufacturability, and design verification and validation. The Associate Product Engineer shall apply engineering principles to his/her essential duties and responsibilities.

Essential Duties and Responsibilities:

• Primary responsibility is assisting with the maintenance of existing medical devices including driving continuous improvement.
• Assist with the development of device designs based on inputs for both new and existing products and product lines.
• Assist with product specifications, prototype development, creation and execution of testing methodologies, and maintenance of detailed documentation to evaluate design feasibility.
• Investigate and report on industry and non-industry technologies.
• Evaluate/investigate design changes, product complaints, and non-conformances; effectively report findings and recommendations as per corporate procedures.
• Assist with the execution of design verification and validation activity.
• Collaborate with the team in assisting with the design and implementation of new methodologies, materials, and/or processes to bring concepts to market.
• Organize, track and process R&D document change requests.
• Initiate the item setup process.
• Participate in in-vitro and in-vivo studies, including animal and human evaluations, as part of the development process.
• Interface and collaborate with Manufacturing, Quality, Regulatory, Research and Development, Sales, Marketing, Accounting, Customer Care, and outside vendors to accomplish assigned tasks.

Qualifications:

• Minimum of 1 year of medical device product design and development experience preferred.
• Experience with MSWindows and MSOffice applications (e.g. Word, Excel, PowerPoint) preferred.
• Experience with CAD design software (e.g. SolidWorks) preferred.
• Ability to interact with colleagues and customers in a professional manner.
• Must possess good written and verbal communication skills

Education:

DENTALIS, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.

Please note that any offer of employment made by Dentalis is contingent upon the successful completion of a pre-employment background investigation to include a pre-employment drug screen.