We are currently seeking a resourceful, energetic individual to help develop new products for the company. The successful candidate will have the ability to develop and execute on-time and on-budget development programs while navigating regulatory and quality system requirements. The candidate must have a proven track record with the ability to excel in a fluid, fast-paced, multi-tasking environment and will work out of AlterG’s campus in Fremont, CA.
- Designing & developing new products, working in conjunction with external consultants and internal resources.
- Transitioning products from product development to production.
- Provide project management oversight when needed for new product introductions, and upgrades to existing products.
- Support manufacturing as needed in the development of alternative manufacturing designs, obsolescence scenarios, or cost reduction opportunities.
- Capable of evaluating cost reduction opportunities and charting the appropriate course of action to optimize ROI on projects.
- Creation and management of risk analysis (per ISO 14971) for projects
- Performing other work-related duties as assigned
- Bachelor’s degree in Mechanical Engineering; Masters preferred
- Minimum of 10 years of related experience with medical devices and/or capital equipment design
- Working knowledge and use of Solidworks, required; experience with Agile PDM systems strongly desired
- Functional knowledge of ISO 13485 requirements, and experience with compliance testing desired
- Experienced in DFM, DFT, Kaizen or Six Sigma skills a plus
- Experience working with soft goods is a plus
- Candidate must have a strong work ethic, capable of being self-directed, and enjoy working with others in a team environment.
Physical Demands and Work Environment
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions. While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 40 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.