Job Description
POSITION SUMMARY:
You are an intrinsically-motivated, hands-on, self-starter who will develop, document, and implement manufacturing processes, equipment, and custom tooling for assembly, testing, inspecting, and packaging of ophthalmic surgical components and disposables. You will
- Report to the Principal Development Engineer, and work closely with the Engineering/R&D, Quality, and Manufacturing/Production Teams.
- Sustain current production, while having opportunity to transfer new products from development to commercialization.
- Evaluate current processes for opportunities to improve efficiency and capacity.
REQUIRED SKILLS AND EXPERIENCE:
Desire 5+ years experience developing and supporting high volume manufacturing processes, tooling, fixtures, and mechanisms.
Must have medical device experience including sterile packaging and verification.
Familiar with GMP and ISO 13485.
Mechanical design, materials, analysis, and manufacturing experience is required.
Electro-mechanical design, analysis and manufacturing experience is strongly preferred.
Experience writing of IQ/OQ/PQ or process validation documents.
Proven track record optimizing manufacturing processes.
Ability to write user friendly, illustrated manufacturing and inspection procedures.
Machining & use of standard hand and power tools is desired.
Works well in teams and independently.
Ability to work and communicate effectively with people from all levels of the organization.
Must be flexible and willing to perform other tasks as assigned.
EDUCATION:
BS in mechanical, industrial, or manufacturing engineering, or equivalent (Relevant experience will be considered for candidates without degree.)