Primary Function of Position:The Project Coordinator will support complex, cross-functional product development programs within Advanced Engineering. This role ensures timely execution of deliverables across subsystems including Instruments, Vision, Software, and Clinical, with a focus on regulatory and clinical readiness. The coordinator will drive operational efficiency, facilitate governance, and support logistical and tactical workstreams as well as strategic initiatives such as V&V deliverables and regulatory submissions.
Job Requirements:- 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
- Coordinate activities defined by the Program or Project Managers
- Support meetings including taking minutes and tracking action items
- Closely track Verification and Validation protocols and reports for Regulatory submissions
- Coordinate logistics related to clinical study readiness and execution including supporting device shipments to clinical sites, tracking and receiving
- Strong collaboration and direct participation with Regulatory during final preparations for submissions
- 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 including assembling presentations, checklists, and action items
- Liaison with Document Control and ECO Change Control Board (CCB) to ensure timely approval
- Familiar with software terminology and software development lifecycle activities and deliverables
- Familiarity tracing documentation in accordance to medical device design control requirements is highly desirable
QualificationsSkills, Experience, Education, & Training:- Bachelor's Degree
- 3+ years of experience in project coordination or program management
- 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
Preferred Skills and Experience- Masters degree
- 2+ years of project coordination or program management experience within a technical or regulated or medical devices environment
This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate's experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate's qualifications, consistent with applicable law.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.
