RedwoodCityRecruiter Since 2001
the smart solution for Redwood City jobs

Staff Engineer

Company: Eyenovia Inc.
Location: redwood city
Posted on: May 3, 2021

Job Description:

About Eyenovia

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 more.


Job Description

Position Title:Staff Engineer

Department:Manufacturing

FLSA Status:Exempt

Job Summary

The individual in this role is responsible for:

Team Leadership

  • 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).

General

  • 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 processing.
  • 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 Operations.

Compliance

  • 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 Control system.

Collaboration

  • Working together with Purchasing and Materials to develop finished goods BOMs and routings, inputting into ERP system, and maintaining database.
  • 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 allocation.
  • Participating in development/maintenance of product design FMEAs.
  • Serving as an independent design reviewer for other projects.
  • The individual fulfilling this role will work closely with the companys Engineering/Product Design, Purchasing/Materials, and Quality teams.
  • Support company management of drug rollout logistics and communication of the companys manufacturing status with Commercial.

QUALIFICATIONS GUIDELINES

Any combination equivalent to, but not limited to, the following:

Experience

  • 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 industry.
  • 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 discipline.

Skills

  • 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 skills.
  • Project management of new product development projects and experience working on/leading cross-functional teams desirable.
  • Experience designing medical device and/or pharmaceutical manufacturing processes.
  • Broad understanding of development processes compliant with 21 CFR 820 and/or ISO 13485.
  • Knowledge and experience with product, process, and software validation.
  • 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 holidays.

Keywords: Eyenovia Inc., Redwood City , Staff Engineer, Other , redwood city, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Redwood City RSS job feeds