- 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).
- 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 risk), ISO packaging).
- Proven start-up or tech-transfer experience (new line/site/equipment).
- Strong CAD (SolidWorks/AutoCAD), MRP/ERP user skills, and excellent technical writing.
- 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.
- 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. xhmxlyz
- Complete, audit-ready DMR and training matrices for each line.
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Senior Manufacturing Engineering - Sarasota - Top Quality Recruitment (TQR)
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Description
Location: Sarasota, FL (on-site)
Type: Full-time | New manufacturing site launch
Are you the right applicant for this opportunity Find out by reading through the role overview below.
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
What you'll bring
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Success indicators (first 6–12 months)
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