Project Manager – Medical Device
Job Description
Project Manager – Medical Device
Locations: On-site | Spring Hill FL | Greater Tampa Bay
Travel: Limited regional travel to suppliers and contract manufacturers as needed.
A rapidly growing designer and manufacturer of precision electro-mechanical components for Class II & III medical technology is expanding its program leadership team. We are looking for a hands-on Project Manager who can bring new products from napkin sketch to full-scale production, all while keeping quality, compliance, and timelines on track. If you thrive in a build-it, own-it environment and want your work to help improve patient outcomes, this is the role for you.
How You Will Make an Impact
- Lead cross-functional squads spanning engineering, quality, manufacturing, and supply chain, guiding projects from concept through production ramp.
- Build and maintain integrated schedules, resource maps, and cost trackers, providing weekly progress snapshots to senior leadership.
- Drive Design History File (DHF) creation and keep audit-ready documentation in adherence with ISO 13485 and FDA QSR requirements.
- Own program-level risk management: establish and maintain DFMEA and PFMEA registers, escalate high-impact issues early, and drive mitigation plans.
- Coordinate validation activities (IQ, OQ, PQ) and ensure a smooth transfer of designs into a controlled manufacturing environment.
- Verify production readiness by confirming tooling, documentation, operator training, and first-article builds meet release criteria.
- Serve as the primary voice to customers, translating technical milestones into clear status reports and action plans.
- Champion a culture of continuous improvement, leveraging lessons learned to shorten future development cycles.
What You Bring
- Bachelor’s degree in mechanical, Electrical, Industrial, or Manufacturing Engineering (or similar).
- 5+ years managing product development or manufacturing projects within a regulated industry; medical device experience strongly preferred.
- Proven track record coordinating cross-disciplinary teams and shipping electromechanical products under ISO 13485 or comparable quality systems.
- Working knowledge of stage-gate or agile product-development processes, DHF creation, DFMEA / PFMEA, and validation protocols.
- Solid command of project-management tools (MS Project, Smartsheet, or similar) and the ability to turn data into decisive action.
- Strong communicator who can influence without authority and keep stakeholders aligned.
- PMP or similar certification is a plus.
Why You Will Love It Here
- Mission-driven culture where your projects directly impact patient safety and quality of care.
- Visible role with executive access and the autonomy to shape best-in-class program processes.
- Competitive salary, performance bonus, and full benefits package.
- Relocation assistance available for the right candidate.
About Blue Signal:
Blue Signal is an award-winning, executive search firm specializing in various specialties. Our recruiters have a proven track record of placing top-tier talent across industry verticals, with deep expertise in numerous professional services. Learn more at /46Gs4yS