About the job
Use multidisciplinary engineering knowledge to design and develop innovative medical devices or components/subsystems in support of company’s strategic plan.
Major duties and responsibilities:
- Apply broad engineering knowledge to the design and development of new products as well as product changes and enhancements which are consistent with a zero defect level as well as low product cost.
- Solve multidisciplinary engineering problems at the component through system level.
- Conduct testing utilizing existing test protocols or develop new ones as needed.
- Complete projects (including product enhancements) in a manner consistent with corporate objectives.
- Contribute to the intellectual property position of the company via invention and patent applications.
- Maintain accurate documentation of concepts, designs, drawings, and processes.
- Ability to coordinate and manage project design history file and associated activities.
- Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products.
- Provide multidisciplinary engineering and technical support of products introduced into both the domestic and international markets as well as physician in-service programs.
- Oversee outside vendors and consultants as required.
- Interact with customers and physicians.
- Maintain GMP systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post production GMP compliance in coordination with the Document Control, Clinical, and Quality Assurance functions.
- Provide multidisciplinary engineering support in the resolution of product complaints and/or safety issues.
- Provide guidance to associate engineers and technicians on engineering/test activities.
- Work with other engineering, manufacturing, clinical affairs, sales and marketing and quality assurance staff to coordinate pilot production of new products.
- Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.
Education and other requirements:
BS Engineering and 5 years’ experience or MS and 3 years’ experience, or equivalent
Working knowledge of engineering terminology and concepts and related software applications (Word, Excel, Project, Solidworks/CAD, Statistical software)
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 stand, walk and sit for extended periods of time. Occasionally the employee will be required to lift or move at least 50 pounds. Spending extended periods of time under a microscope. Travel may be expected upwards to 25% of time.
Interested candidates should submit their resume to firstname.lastname@example.org with the job title as the subject.
Resumes from recruiters will not be accepted.