Project Manager – Design Control Remediation Program

MB&A

Project Manager overseeing design control remediation for medical device firm; ensuring compliance with ISO 13485 and EU MDR requirements.

Posted 5/1/2026contractRemote • Florida • 🇺🇸 United StatesSeniorLeadWebsite

Tech Stack

Tools & technologies

PMP

About the role

Key responsibilities & impact

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.
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.
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.
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.
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

What you’ll need

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.
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

Comp & perks

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.

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Applicant Tracking System Keywords

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Hard Skills & Tools

program managementrisk managementbudget trackingmilestone trackingdependency mappingdesign control remediationDHF remediationtraceability remediationV&V protocol developmentregulatory submission support

Soft Skills

executive presencecommunicationleadershipproblem-solvingprioritizationcoordinationconflict resolutiontransparencyauditingclient management

Certifications

PMPLean Six Sigma Black BeltLean Six Sigma Green BeltCSMCSPO