Top Quality Recruitment (TQR) · 14 hours ago
Senior Manager Manufacturing Engineering
Sarasota, FL
Full-time
Onsite
Senior Level
5+ years expTop Quality Recruitment (TQR) is seeking a Senior Manager Manufacturing Engineering to lead the establishment of a sterile medical-device manufacturing operation. The role involves overseeing process design, validation, and facility management to ensure commercial readiness of products while collaborating with various teams to meet regulatory standards.
RecruitingSmall and Medium BusinessesStaffing Agency
Hiring Manager
Elaine Bonin
Responsibilities
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)
Qualification
Required
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
Preferred
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
Company
Top Quality Recruitment (TQR)
Top Quality Recruitment is a leading provider of workforce solutions to clients in Food & Beverage Manufacturing, Consumer Packaged Goods and Life Sciences.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Elaine Bonin
Recruitment Partner - Recruiting | Recruitment | Retained Executive Search | HR
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