Sr. Engineer I/II @ Groe Advisors LLC - San Clemente, CA

Job Overview

2 months ago

Sr. Engineer I/II

Groe Advisors LLC - San Clemente, CA

Overview

The Senior Engineer II located in San Clemente, CA Perform a variety of mechanical engineering activities on the ocular related products including product design, concept prototyping, concept testing, early development, clinical builds, manufacturing scale up development and sustaining activities. Responsibilities include developing creative solutions to design and manufacturing problems, ensuring the proper engineering deliverables are accurately generated, generation of 3D CAD models, 2D CAD drawings, test procedures, etc, project management/ leadership, maintaining schedule and product release plans. This individual will may lead project teams with other engineers, designers, and manufacturing staff with a focus on meeting product specifications with technically strong, high quality, cost effective designs following Glaukos’s defined development process. Further, all duties shall be performed in a professional way with attention to detail while supporting Glaukos’ Quality Policy and the appropriated regulatory agencies, including FDA Quality System Regulations (21 CFR 820), ISO Standards (EN ISO 13485) and Risk Management (EN ISO 14971).

Responsibilities

Contribute to development of new designs, manufacturing processes, and other engineering / business processes at all stages, from concept creation to production release.

  • Assists in or develops implantable Class III ophthalmic medical devices and the associated insertion system.
  • Responsible for applying fundamental and advanced (depending on level) mechanical engineering principles, concepts, theories and techniques to solve complex problems related to product development / design and manufacturing while following company standard practices and procedures, and related specification.
  • Responsible for generating proper engineering design models using SolidWorks 3-D parametric modeling software.
  • Responsible for generating proper documentation including detailed 2-D part drawings, assembly drawings, engineering test protocols, engineering test reports, validation protocols , validation reports and other associated engineering documentation using, SolidWorks, MS Office Suite, etc. while ensuring proper engineering control guidelines are met and the appropriated level of detail is used.

Requirements

  • BS Mechanical Engineering or equivalent required
  • MS Engineering or MBA preferred
  • 5+ years of experience working as design and research engineer
  • Strong knowledge of cGMP and ISO regulations required and ability to support regulatory filings and company regulatory / quality audits
  • Ability to author V&V and all DHF deliverables.
  • Assists in or development completed per project plan with defined milestones, which are defined by the project engineer, but approved by the team and management.
  • Development work is completed to ensure safe and effective products that meets all worldwide quality, regulatory, marketing requirements.

Job Type: Full-time

Pay: $113,000.00 - $145,000.00 per year

Benefits:

  • 401(k)
  • Dental insurance
  • Health insurance
  • Paid time off

Schedule:

  • Monday to Friday

Supplemental pay types:

  • Bonus pay

Ability to commute/relocate:

  • San Clemente, CA 92672: Reliably commute or planning to relocate before starting work (Required)

Education:

  • Bachelor's (Required)

Experience:

  • engineering: 5 years (Preferred)
  • working within cGMP and ISO regulations: 5 years (Preferred)
  • authoring V&V paperwork: 5 years (Preferred)
  • pharmaceutical industry: 5 years (Preferred)
  • working with chemicals: 5 years (Preferred)

Work Location: One location

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