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Sr. Manufacturing Engineer, Operations Systems

4 hours, 49 minutes ago
United States
Full-time
Senior
Project Manager
Project and Program Management
Apply Now
Penumbra

Penumbra

Penumbra Inc is a global healthcare company focused on innovating novel technologies to address challenging medical conditions in neuro and peripheral vascular markets. They design, develop, manufacture, and market medical devices for interventional th...

Health Care Providers & Services
1K-5K
Founded 2004
View All Jobs 25

Description

  • Lead cross-functional teams to plan and implement changes and improvements to operational systems and manufacturing processes.
  • Create and execute integrated project plans and manage project performance through completion.
  • Develop new processes for medical devices and components.
  • Provide engineering support for existing devices in manufacturing.
  • Create and modify product design specifications and production or R&D drawings.
  • Document manufacturing and production development activities through lab notebooks, engineering protocols, and engineering reports.
  • Identify, evaluate, and manage vendors supporting process development.
  • Research and integrate new technologies into existing and future products and processes.
  • Evaluate and troubleshoot problems, determine root cause, and recommend corrective actions.
  • Communicate project status, risks, assumptions, timelines, and escalations across functional teams.
  • Lead cross-functional discussions to resolve project issues and mitigate risks.
  • Provide technical direction, guidance, and review to less experienced team members and cross-functional partners.

Requirements

  • Bachelor’s degree in Mechanical, Biomedical, Electrical, Chemical, Materials, or Industrial Engineering, or a related degree, plus 4+ years of relevant engineering experience, or an equivalent combination of education and experience.
  • Master’s degree preferred.
  • Detailed knowledge of GMP and Quality System Regulations, including clean room environment practices.
  • Demonstrated knowledge of engineering and scientific principles.
  • Engineering experience in a manufacturing environment recommended; medical device industry experience preferred.
  • Excellent written, verbal, and interpersonal communication skills.
  • Knowledge of FDA regulations, Lean/Flow Manufacturing, and/or materials and manufacturing processes desired.
  • Proficiency in Word, Excel, PowerPoint, Access, and other computer applications.
  • High degree of accuracy and attention to detail.
  • Strong organizational skills with the ability to prioritize multiple assignments and projects simultaneously.

Benefits

  • Starting base salary of $113,000 to $157,000, based on state of residence.
  • Work across general office, laboratory, and cleanroom environments.
  • Opportunity to work remotely as indicated in the posting.
  • Exposure to multidisciplinary engineering and cross-functional project work.
  • Hands-on work supporting medical device manufacturing and development.

Interested in this position?

Apply directly on the company website

Apply Now

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