Project Manager for Medical Device Company
Company: Wave Neuroscience
Position: Project Manager - Medical Device
Location: Newport Beach, California
Posted: April 22, 2021
As a Project Manager – you will be responsible for coordination, planning, and ensuring regulatory requirements are met for ongoing medical device and software product development at Wave Neuroscience.
- Engage with and ensure agreements and payments are in place for contract design firms, contract manufacturers, and consultants associated with product development.
- Determine budget and schedule estimates for projects and present those to the executive team as necessary.
- Understand our Quality Management System (QMS), and ensure that all required documentation is created, submitted, and approved as per the Company’s SOPs. Note that some of these documents will need to be drafted by you and some drafted by contractors and consultants
- Manage the product Design History File and Device Master Record.
- Ensure that qualifications are performed for all vendors, suppliers, and contractors.
- Manage inventory of materials and ensure that the Contract Manufacturer is able to provide devices in a timely manner.
- Prepare for and participate in any FDA audits that arise.
- Support clinical trial efforts by providing necessary documentation for IDE/IRB submission.
This Position Requires the Following Skills and Attributes
- Sc. or equivalent post-secondary education in a science-related field or with significant science course-work
- Technical background in engineering or biological/physical sciences
- Experience with mechanical and electrical medical devices and software
- Minimum of 5+ years of experience in Medical Device Design
- Working knowledge of regulatory requirements for the design of medical devices and software
- Experience in writing design documentation
- Experience reviewing and approving technical documentation
- Ability to work independently and as part of a team
- Strong writing, verbal and interpersonal communication skills
- Strategic minded, analytical and detail oriented
- Proficiency with computers (Microsoft Office Suite, Adobe Acrobat) and general office equipment
- Work mostly on-site in Newport Beach, CA
The following skills and attributes are preferred:
- Training in Quality Systems
- Managed a Class II medical device project from planning through manufacturing
- Experience in an ISO 13485 certified environment