Project Manager — Design Control Remediation Program

This is a remote position.

Project Manager — Design Control Remediation Program

Medical Device | ISO 13485 / EU MDR | 1099 Independent Contractor

Engagement Type: 1099 Independent Contractor

Schedule: Part-time, 20–24 hours per week

Duration: 12 months, with potential extension

Location: Remote (U.S.)

Travel: Up to one week per month to client site in Gainesville, FL (fully reimbursed)

Reports To: Chief Executive Officer, MB&A

Client Interface: Client executive leadership and program steering committee

About MB&A

Monica Burt & Associates (MB&A) is a specialized consulting firm supporting medical device manufacturers in quality systems, regulatory strategy, operational transformation, and product development. Our team consists of seasoned industry leaders with deep expertise across the medical device ecosystem, including orthopedics, cardiovascular, spine, enabling technologies, and advanced surgical platforms.

MB&A has supported 40+ ISO 13485 compliance initiatives, global regulatory submissions, EU MDR transitions, and large-scale remediation programs for medical device manufacturers across Class II and Class III product portfolios.

Engagement Overview

MB&A is seeking an experienced Project Manager to lead a Design Control Remediation Program for a growing medical device manufacturer. This is a high-visibility engagement focused on strengthening design controls, updating technical documentation, and ensuring sustained compliance with ISO 13485 and EU MDR across Class II and Class III device portfolios.

The Project Manager will serve as MB&A's program lead, coordinating a team of 6–8 MB&A consultants (Senior and Principal Design Quality Engineers), managing the consolidated project funnel of client resource requests, and interfacing directly with MB&A's CEO and the client's executive leadership. The role demands strong executive presence, disciplined program governance, and the ability to escalate and resolve risks before they impact deliverables or timelines.

Key Responsibilities

Program Leadership & Governance

· Lead end-to-end program management for the Design Control Remediation initiative, including planning, scheduling, risk management, budget tracking, and reporting.

· Establish and maintain the master program schedule, milestone tracking, and dependency mapping across all workstreams.

· Serve as the primary point of escalation for program risks, issues, and resource conflicts.

Consultant Coordination & Oversight

· Provide dotted-line operational oversight to 6–8 MB&A consultants assigned to the program (consultants report directly to MB&A's CEO).

· Coordinate consultant assignments, deliverable cadence, and quality of work product against program milestones.

· Identify performance, capacity, or scope issues that cannot be resolved at the consultant level and escalate promptly to MB&A's CEO.

Client Resource & Project Funnel Management

· Act as the single intake point for all client-side resource requests, controlling the source and flow of work into the consulting team.

· Prioritize and sequence work to align with the client's tight remediation timelines and the criticality of compliance deliverables.

· Maintain a transparent, auditable record of intake, prioritization decisions, and resource allocation.

Executive Communication & Stakeholder Engagement

· Lead weekly client steering committee calls, including agenda, materials, and follow-ups.

· Deliver a minimum of one monthly executive readout to MB&A's CEO and the client's executive leadership, summarizing progress, risks, decisions required, and forward outlook.

· Maintain a high standard of executive-ready written and verbal communication; represent MB&A as a trusted partner at the leadership table.

Quality, Compliance & Documentation Oversight

· Ensure program activities — including DHF assessments, design review facilitation, traceability remediation, V&V protocol development, and EU MDR technical documentation updates — are delivered to MB&A and client quality standards.

· Drive disciplined documentation close-out and deployment.

Requirements

Required Qualifications

· Active PMP (Project Management Professional) certification from the Project Management Institute.

· Lean Six Sigma certification (Black Belt preferred; Green Belt considered).

· Proven ability to manage multi-workstream programs with 6+ consultants or cross-functional team members.

· Executive presence: confident, concise, and credible in front of C-level leadership on both client and consulting sides.

· Ability to travel up to one week per month (fully reimbursed).

· Eligible to work in the United States as a 1099 independent contractor. No C2C arrangements or visa sponsorship will be considered.

Preferred Qualifications

· Additional certifications such as CSM or CSPO.

· Experience leading remediation programs in response to FDA observations, Notified Body findings, or internal compliance assessments.

· Direct medical device industry experience leading or program-managing initiatives for Class II and/or Class III devices.

· Demonstrated experience with design control remediation programs, including DHF remediation, design review governance, and traceability between design inputs, risk controls, and verification activities.

· Working knowledge of QMSR, ISO 13485, EU MDR (Regulation (EU) 2017/745), and ISO 14971.

· Background in orthopedic, cardiovascular, spine, or SaMD product portfolios.

· Experience operating within a consulting model and managing 1099 / contract resources.

· Familiarity with usability engineering (IEC 62366), clinical evaluation documentation, or regulatory submission support.

Benefits

What MB&A Offers

· A high-impact, executive-visible engagement on a strategic remediation program for a growing medical device manufacturer.

· Direct collaboration with MB&A's CEO and a team of seasoned medical device consultants.

· Long-term relationship potential — MB&A frequently engages high-performing consultants on multiple programs across our client portfolio.

· Competitive 1099 hourly compensation, commensurate with experience and certifications.