Senior Manufacturing Engineering

Location: Sarasota, FL (on-site)

Type: Full-time | New manufacturing site launch

The mission: Stand up a sterile medical-device manufacturing operation from the ground up. You’ll lead process design and validation for an initial portfolio of 3 products, build and qualify cleanroom production, and partner closely with Quality/Regulatory, Documentation, and Manufacturing Technicians to reach commercial readiness. Deep technical expertise in precision manufacturing is required.

What you’ll do

• Greenfield setup: Specify, source, and commission production equipment; design cell layout, material flow, and environmental controls for ISO-class cleanrooms.
• Process development & validation: Author and execute IQ/OQ/PQ; develop robust, statistically controlled processes (DOE, SPC, MSA, GR&R).
• Sterile manufacturing readiness: Establish validated sterilization pathways (e.g., EtO, gamma, or e-beam) and packaging validations per ISO 11607.
• Documentation: Create/own DMR/DMRIs, pFMEAs, control plans, work instructions, and change control with full revision discipline.
• Quality systems partnership: Work hand-in-hand with QA/RA to meet FDA 21 CFR 820 / ISO 13485; support internal/external audits and CAPA/RCA.
• Scale & throughput: Build line balance, takt, and capacity models; drive scrap/downtime reduction; implement error-proofing (poka-yoke), visual controls, and standard work.
• Training & leadership: Mentor techs; transfer processes to production; build operator certification plans.
• HSE & compliance: Enforce cleanroom behaviors (gowning, environmental monitoring, bio-burden/particulates), EHS, and OSHA requirements.
• Launch metrics: Hit PPAP/first-article targets (where applicable), release lots to spec, and meet cost/quality/delivery objectives.
• Manufacturing Operations & Facility Management
• Manage day-to-day manufacturing facility operations; oversee precision welding, annealing, material processing, fabrication, and assembly.
• Lead vertical integration initiatives including technology transfer, equipment selection, installation, qualification, and process development.
• Develop and validate process parameters; ensure capacity planning meets production demands while maintaining quality standards.
• Monitor equipment utilization, uptime, and overall equipment effectiveness (OEE).

What you’ll bring

• BS in Engineering (Mechanical, Manufacturing, Biomedical, or related).
• 5–10 years in medical-device manufacturing, including cleanroom assembly/packaging and sterile product lines.
• Hands-on with IQ/OQ/PQ, PFMEA/Control Plan, DOE, and statistical tools.
• Familiarity with ISO 13485, 21 CFR 820, ISO 14971 (risk), ISO 11607 (packaging).
• Proven start-up or tech-transfer experience (new line/site/equipment).
• Strong CAD (SolidWorks/AutoCAD), MRP/ERP user skills, and excellent technical writing.

Nice-to-haves

• Sterilization validation (EtO/gamma/e-beam) ownership; packaging seal integrity and transit testing.
• Six Sigma/Lean cert (Green/Black Belt).
• Automation/vision systems, fixture design, and validation.
• Supplier/process PPAP; IQC controls.

Success indicators (first 6–12 months)

• Cleanroom qualified; processes validated (IQ/OQ/PQ) for 3 products.
• FPY ≥ 95% on released lots; scrap ≤ 2–3% by month 6.
• On-time delivery ≥ 98% after ramp; no major audit findings.
• Complete, audit-ready DMR and training matrices for each line.