About the Role
The Senior Manufacturing Engineer will be responsible for designing, installing, validating, and optimising production processes from scratch. This role involves establishing production lines, ensuring compliance with FDA and ISO 13485 standards, and setting up quality control systems in a brand-new facility.
Key Activities
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 sterilisation 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 behaviours (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 utilisation, uptime, and overall equipment effectiveness (OEE).
Preferred Skills
Sterilisation 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.
Education and Experience
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).
About Us
Finding a great opportunity that fosters growth, a great culture, and leadership opportunities can be difficult. Top Quality Recruitment (TQR) connects professionals with leadership opportunities across the Packaging, Food and Beverage, Medical Devices, and Biotechnology industries. With 50+ years of experience, we believe in one-to-one communication and finding the best candidate/employer match possible.
TQR is an equal-opportunity employer that encourages diversity. We will consider all applications.
Accommodation for applicants with disabilities is available upon request.
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