What are the responsibilities and job description for the Medical Device Product Development Lead position at Atraverse Medical, Inc.?
Atraverse Medical, Inc. is a fast-paced startup that is looking for a Medical Device Product Development Lead to oversee the entire lifecycle of our electrosurgical system from product development to launch and sustaining support.
The successful candidate will have a strong background in electrical or systems engineering with a minimum of 10 years of experience in design/engineering for medical device development and/or manufacturing. They will be able to work closely with our internal and external development and manufacturing teams to ensure timely completion of projects.
A key aspect of this role is managing multiple competing priorities while working independently and in project team settings. The ideal candidate will have excellent communication skills, both written and verbal, and be able to influence others to achieve company objectives.
The Medical Device Product Development Lead will be responsible for leading technical activities for various elements of an electrosurgical system throughout all stages of the product lifecycle, reviewing existing or developing project schedules to identify strategies to de-risk timelines, and interfacing closely with suppliers on a daily basis to review project status.
- Prepare technical documentation, including manufacturing instructions, test methods, protocols, and reports, to support design control activities and regulatory submissions
- Manage 60601 and other electrical safety and EMC, MRI safety, and radio regulation (FCC, RED, etc.) compliance activities
