Careers

Job Posted: 5/5/2024

Job Title: Research & Development Engineer
Reports to: Quality Manager

Summary:

Performs various engineering related activities in support of new product development and life cycle management of existing products.

Responsibilities:

Duties and responsibilities include the following, other duties may be assigned.

• Conduct research and development activities
• Apply relevant research theories, principles, and models when conducting experiments and research activities.
• Design and create prototypes of new devices both functional and non-functional.
• Analyzes prototypes and first builds, conducts product tests accordingly.
• Summarizes research results and communicates findings internally.
• Establish and maintain applicable Design History Files for new products in accordance with the QMS and in support of applicable regulatory requirements and registrations.
• Support all regulatory requirements for FDA and ISO testing and related documentation requirements.
• Develops and documents technical specs, sketches, drawings and materials required for manufacturing.
• Supports and contributes to VTIs intellectual property/patentable ideas organization value.
• Assists in maintaining Engineering Lab spaces.
• Production training as required.
• Assist in design and produce specific and unique tooling.
• Supports all departments where needed.

Skills:

• Oral Communication Skills
• Written Communication Skills
• Professionalism
• Project Management
• Time Management

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Language Ability:

Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Math Ability:

Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Reasoning Ability:

Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

Computer Skills:

To perform this job successfully, an individual should have knowledge of Microsoft Word and Microsoft Excel.

Education/Experience:

Bachelor’s Degree. Prior medical device development experience a plus.

Knowledge, Skills and Other abilities:

• Knowledge of ISO 13485, FDA Medical Devices Good Manufacturing Practices Part 820
• Knowledge of EU medical device regulation and other applicable country regulations

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use hands; reach with hands and arms and talk or hear. The employee is frequently required to stand and sit. The employee must frequently lift and/or move up to 25 pounds.