471 El Camino Real Santa Clara, CA 95050 US
- Conduct design verification and validation testing for product development activities
- Oversee R&D lab activities including but not limited to mechanical testing, equipment maintenance, fixure development
- Support all technical aspects of the product and instruments.
- Support regulatory requirements.
- Support the design control process.
- Support sustaining engineering activities with root cause and engineering analysis
- Lead engineering change process.
- In the event of potential non-compliance with applicable standards or regulations (e.g. FDA QSRs, ISO 13485, or ISO14971), the employee has the authority to hold any product or QA/RA documentation from shipment or further processing. The employee has the responsibility to report any instances to their direct supervisor or above.
- The Research Engineer must at all times act and conduct company business in an honest, ethical, and strictly legal manner, complying with the Code of Conduct, other company policies, the AdvaMed Code, and all applicable laws and regulations, whether national, regional, state or local. This individual is encouraged, expected, and required to report any suspected violations of laws, regulations, the Code, or any other Company policy, and all other suspected unethical behavior. The company does not tolerate retaliation in connection with making good faith reports of suspected violations.
- Assist the R&D group in developing products to ensure constantly improved instrumentation and cutting-edge technology.
- Write protocols, conduct testing, and write test reports.
- Perform mechanical testing of product and instruments (including the development of fixtures)
- Assist in repair and preventative maintenance of equipment.
- As needed, source appropriate vendors to conduct testing and oversee their testing
- BS in an engineering discipline (Mechanical engineering preferred)
- Currently or recently served as a research engineer for a high-growth, medical device organization whose products are marketed to a medical specialty practice and worked in that capacity for a minimum of 3 years. Experience in orthopedics is highly desired, spine experience also a plus.
- Currently or recently performed testing to established standards (i.e. ISO, ASTM).
- Currently or recently performed repair and/or preventative maintenance of equipment.
- Good writing skills.
- A passion for supporting an emerging company and sustaining high growth through engineering support.
- A superior functional background in engineering and testing of medical devices.
- Have a demonstrated ability to communicate effectively and work well with co-workers, surgeons, clinicians, and distributor reps.
- Have a working cross-disciplinary understanding of a medical device business emphasized on engineering, manufacturing, operations, R&D, clinical and regulatory, and quality assurance.
- Be a proactive person who attacks problems, displaying initiative and perseverance in order to bring about meaningful change, and to be open and responsive to new ideas.
- Be known as a person who has high integrity, sound character, a tremendous work ethic, and the passion to succeed.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.