Engineering Jobs in Weeki Wachee Gardens, FL

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

Must Haves:

• Associate's Degree in Biomedical Equipment Technology or related Field
• Basic understanding of electronics, mechanical systems, and medical equipment

Plusses:

• Experience with Philips Monitor or MindRay equipment

Day to Day:

Supporting the Clinical Engineering department through equipment inventory management, asset tagging, equipment monitoring, and basic maintenance activities. This role works under the guidance of senior biomedical technicians and clinical engineers to ensure medical equipment is accurately tracked, properly maintained, and compliant with safety and regulatory standards.

Manufacturing Engineer – FDA/ISO

Location: On-Site in Spring Hill, FL and Dunedin, FL

Are you a detail-driven Manufacturing Engineer who thrives in highly regulated environments and takes pride in building processes that stand up to FDA and ISO scrutiny? A rapidly growing medical device manufacturer in the Tampa Bay region is expanding its engineering team and seeking a hands-on leader to strengthen process integrity, validation execution, and production readiness across two Florida facilities.

This is a high-impact role for someone who enjoys owning documentation, driving validation strategy, and partnering cross-functionally to ensure manufacturing operations are audit-ready, efficient, and scalable. You will serve as the critical bridge between Engineering and Production, helping bring complex medical products from design into robust, compliant manufacturing environments.

Why This Role

This position is ideal for an engineer who values structure, compliance, and precision while still enjoying collaboration on the production floor. You will play a central role in strengthening systems that directly impact product quality, regulatory success, and patient outcomes.

Key Responsibilities

Process Development and Regulatory Documentation

• Develop and maintain manufacturing routers, work instructions, and standard operating procedures that support controlled production environments.
• Create and manage process flow diagrams and Process Failure Mode and Effects Analyses to proactively mitigate risk.
• Lead and support equipment and process validations including Installation Qualification, Operational Qualification, and Performance Qualification.
• Oversee First Article Inspection activities and ensure complete traceability and documentation accuracy.
• Partner with Quality to establish and maintain Production Part Approval Process documentation.
• Evaluate and improve tooling and fixtures, designing new solutions using CAD tools such as SolidWorks when needed.

Quality Systems and Compliance

• Design and implement incoming inspection protocols for raw materials and components.
• Investigate nonconforming material trends, lead root cause analysis efforts, and define effective rework strategies.
• Contribute to CAPA efforts and assist in maintaining compliance for internal and external audit processes.
• Conduct and analyze Statistical Process Control studies to monitor process stability and drive measurable improvements.

Production Support and Continuous Improvement

• Train production personnel on new procedures, documentation updates, and equipment changes.
• Provide technical troubleshooting support to resolve manufacturing challenges and improve capability.
• Collaborate cross-functionally to reduce waste, improve yield, and enhance operational efficiency.
• Drive initiatives that strengthen process robustness and long-term regulatory compliance.

Required Qualifications

• Bachelor’s degree in mechanical engineering, Manufacturing Engineering, Biomedical Engineering, or related technical field.
• 3 to 5 years of experience in an FDA-regulated manufacturing environment, medical device experience strongly preferred.
• Demonstrated expertise with ISO 13485 quality systems.
• Hands-on experience leading or supporting IQ, OQ, PQ validations.
• Working knowledge of PFMEA, FAI, PPAP, SPC, and CAPA processes.
• Proficiency with CAD software and ERP systems.
• Strong documentation ownership and technical writing skills.

Preferred Qualifications

• Experience with statistical analysis tools such as Minitab.
• Background supporting internal or external ISO or FDA audits.
• Experience balancing documentation-heavy responsibilities with hands-on production floor engagement.

If you are ready to take ownership of manufacturing process integrity within a growing medical device organization, we would welcome the opportunity to speak with you.

About Blue Signal:

As an award-winning executive search firm, Blue Signal has a strong track record of placing top talent in the manufacturing & industrial space, with expertise in manufacturing leadership, engineering, supply chain, and logistics roles. Leare more at /3D3a7NH