Company: Eyenovia Inc.
Location: redwood city
Posted on: May 3, 2021
Eyenovia is a clinical stage, ophthalmic biopharmaceutical
company that is transforming therapies primarily for the treatment
of progressive myopia, presbyopia, and improving diagnostic eye
exams. We believe our breakthrough technology enables these
first-in-class microdosed therapies that are designed to reduce
ocular and systemic toxicity and improve the risk-benefit profile
of both new and existing drugs. Visit http://eyenovia.com/ to learn
Position Title:Staff Engineer
The individual in this role is responsible for:
- Leading technical efforts related to sterile drug vial
Fill-&-Finish facility (Redwood City, CA).
- Working with the Product Development (PD) Engineering and
Production groups to design, develop, test, and implement
processes, tooling, and fixtures for products.
- Leading and/or actively participating in product/process
engineering problem resolution.
- Leading and/or actively participating in process/product
improvement projects (in cooperation with product development
engineers and technicians).
- Leading effort to develop/maintain process Failure Modes and
Effects Analyses (pFMEAs).
- Collecting data and analyzing process performance and
capabilities for company products, including new products as well
as products already in production.
- Performing tolerance analyses for components, manufacturing
materials, packaging, and supplies used for in-house
- Identifying requirements, advising Operations management,
preparing proposals & acquisition arrangements, and implementing
equipment and/or fixturing for PD and manufacturing efforts.
- Developing and maintaining documentation for design control,
product configurations (e.g., bills-of-materials), and other
Quality System requirements.
- Performing productivity and costing analyses (e.g., calculate
direct labor & materials costs for new products, identify and
implement cost reduction plans for existing products).
- This position will report to the VP of Manufacturing and
- Managing daily compliance with GMP (Good Manufacturing
Practices), quality requirements (e.g.,ISO13485 compliance),
regulatory, and safety standards.
- Assisting Materials and Engineering departments with supplier
selection and technical development, supplier qualification, and
supplier audit programs.
- Managing and updating Manufacturing Instructions (MIs), Work
Instructions (WIs) and Lot History Records (LHRs) within Document
- Working together with Purchasing and Materials to develop
finished goods BOMs and routings, inputting into ERP system, and
- Working together with Quality and Purchasing/Materials to
facilitate completion of OEM/component process validation
activities at supplier sites.
- Assisting with production planning and resource
- Participating in development/maintenance of product design
- Serving as an independent design reviewer for other
- The individual fulfilling this role will work closely with the
companys Engineering/Product Design, Purchasing/Materials, and
- Support company management of drug rollout logistics and
communication of the companys manufacturing status with
Any combination equivalent to, but not limited to, the
- Six or more (6+) years of experience, including three or more
(3+) years of hands-on engineering experience in a startup company
in medical device, pharmaceutical, and/or other regulated
- Knowledge of and experience with Quality System Requirements
(e.g., QSRs, ISO & MDD requirements).
- Strong written and verbal communication skills to communicate
effectively at all levels.
- Bachelors degree in Manufacturing Engineering or related
- Highly motivated, goal-oriented achiever with ability to
prioritize and independently organize work.
- Must possess good mechanical intuition with attention to
detail, excellent problem-solving skills, and organization
- Project management of new product development projects and
experience working on/leading cross-functional teams
- Experience designing medical device and/or pharmaceutical
- Broad understanding of development processes compliant with 21
CFR 820 and/or ISO 13485.
- Knowledge and experience with product, process, and software
- CAD - working knowledge of Solidworks or another parametric
modeling system is a plus.
- Proficiency with written and spoken English with strong
written, verbal, and interpersonal communication skills.
- Experience with ERP software required; experience implementing
new ERP solutions desirable.
- Expertise in Microsoft Office applications.
Physical Requirements: standing, sitting, walking, stairs, light
lifting, computer operation.
Eyenovia is an equal opportunity employer. Eyenovia offers a
competitive benefits package including medical, dental, PTO, and
Keywords: Eyenovia Inc., Redwood City , Staff Engineer, Other , redwood city, California
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