Job Summary

Join us and become a member of an entrepreneurial team that helps Medtech innovators take flight by supporting the design and development of innovative new products within a medical device consultancy, Avio MedTech Consulting. You will help radically advance the Medtech development process across multiple products. As a contributor of the Product Development team within the organization, you will be on the leading edge of meaningful impact to patients, physicians, and payors in a small, fast-paced and innovative environment.

The main objective of the PD/PM II position is to guide our clients through the development process, ensuring appropriate risk management activities are performed and a robust design history file is documented. As a project manager, this position will work shoulder to shoulder with our clients ensuring major business and design milestones are achieved. A well organized, flexible, and quick learner with an entrepreneurial spirit is a must.

The PD/PM II role is responsible for preparing, tracking, managing, and communicating project plans across multiple product development programs. This person plays an essential role as part of the project teams, working with the core team members to develop and execute project and business plans, and support efforts from product concept through commercial launch across a variety of clients.

Responsibilities Include:

Project Management:

• Defining project scope, goals, and deliverables

• Creating detailed project plans, schedules, and timelines

• Allocating resources

• Identifying potential risks and developing mitigation strategies

• Monitoring project progress and performance through regular updates and reporting

• Helping manage and direct activities with various vendors and contract manufacturers (e.g. contract suppliers, test houses, etc.)

• Serving as primary point of contact for stakeholders

• Facilitate regular meetings to update stakeholders on progress

• Manage stakeholder expectations and address concerns

Support Design Control:

• Ensure designs meet performance specifications, regulatory and manufacturing requirements

• Supports Regulatory Affairs in designing and implementing regulatory strategies and provides support of submissions, device labeling and promotional materials

• Maintain Design History Files

• Prepare documentation release packages, including detail drawings, bills of material, and/or procedures Approve Document Change Orders (DCOs) and obtain approvals from others as required

• Promptly respond to product issues, taking appropriate action within Avio’s Quality System and continually building strong rapport with customers and suppliers

• Collaborate with all departments to develop optimal work order routings and Device History Records

• Lead the generation of redlined documentation and review prior to sign off

• Develop V&V testing strategy, ensure appropriate execution