Duration: 1 year
Location: Sunnyvale, CA
Amick Brown is seeking a Senior Project Coordinator to support new product development projects with heavy software components for a customer in the medical device industry.
Skills & Experience:
- The Project Coordinator will define, track, and facilitate SOP requirements and activities to ensure Design Control compliance. A large responsibility is to coordinate the writing and release of documentation during the design phase.
- Work with Program Managers tracking project plans, risk management plans, documentation, and tasks
- Succinctly monitor and report status: project milestones, documentation, action items, and deliverables
- Review projects for variances to schedule
- Proactively organize efforts to alleviate bottlenecks and speed execution
- Coordinate activities defined by the Program Manager
- Support/Lead meetings including taking minutes and tracking action items
- Initiate and implement business process improvements when gaps are identified
- Manage milestones and activities across Development, Quality Assurance/Test, and Operations members
- Closely track Verification and Validation protocols and reports for Regulatory submissions
- Strong collaboration and direct participation with Regulatory during final preparations for submissions
- Solid understanding of Quality Systems or Design Controls for Medical Devices
- Agile (ACCS) originator experience initiating ECOs
- Setup Design History File (DHF) structure; work with team to ensure DHFs are updated and accurate
- Coordinate design and phase gate reviews – Assembling presentations, checklists, and action items
- Liaison with Document Control and ECO Change Control Board (CCB) to ensure timely approval
- Bachelor’s Degree required. Master’s degree preferred.
- 5+ years of directly related experience desired, medical devices experience strongly
- Familiar with software terminology and software development lifecycle activities and deliverables
- High familiarity tracing documentation in accordance to medical device design control requirements
- Must be proactive, a key influencer, detail-oriented, and possess investigative skills.
- Good organizational and investigative skills; proactive problem solving
- Excellent verbal and written communication skills
- Ability to quickly switch between many different projects
- Familiar with waterfall and SCRUM project management
- Proficient in Word, Excel, PowerPoint, Project, Smartsheet, or other similar tools
- Proficient in ALM tools (such as MKS or Polarion), Oracle/Agile, and JIRA
- Specialized training in a discipline such as computers and/or planning and scheduling
Amick Brown, LLC is an Information Technology consulting company providing IT staffing and managed solutions. Founded in 2010, we are a certified woman-owned small business headquartered in San Ramon, CA with an additional office in Sacramento, CA. Amick Brown’s experienced IT professionals support customers nationwide in both the commercial and public sectors. We are SBA 8(a) and IS0 9001:2015 certified and are an SAP Services Silver Partner.
Regular full-time employees are eligible for the following Amick Brown provided benefits:
- 401k with company match
- Paid time off
- Sick Leave
- Short-Term Disability
- Life Insurance
- Wellness & Discount Programs