Manufacturing Engineering Manager - Metals at Penumbra Inc

Alameda, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Manufacturing, Medical DevicesIndustries

Requirements

Bachelor’s degree in an engineering or related technical field with 5+ years of relevant experience, or an equivalent combination of education and experience
Preferred: Master’s degree
Medical device experience required
Detailed knowledge of GMP/Quality System Regulations and clean room environment practices
Outstanding knowledge of engineering and scientific principles

Responsibilities

Manage the manufacturing engineering functions of development projects within a multidisciplinary project team
Manage the development, implementation, and maintenance of processes and equipment for manufacturing of products to achieve cost effectiveness and product quality
Navigate Quality System fluently and lead others through quality system justifications
Select, manage, train, and develop staff; establish objectives and assignments and provide ongoing feedback through performance reviews and development plans
Manage direct reports to execute tasks and achieve goals
Lead cross-functional teams fluently through agreed-upon strategic guidance
Provide engineering support to operations as needed and lead other engineers
Execute tasks independently without requiring assistance or guidance
Recommend vetted solutions proficiently and generate unique projects independently
Work with product development teams to ensure design for manufacturability
Create drawings for Production and Research and Development
Document manufacturing and production development processes through lab notebooks, engineering protocols, and engineering reports
Identify and utilize vendors in the development of processes for products
Perform research and integrate new technologies into existing and future products and processes
Train engineers, technicians, and assemblers in new processes and methods
Evaluate and troubleshoot problems to assess root cause and corrective action
Interpret and communicate test results
Document findings and recommendations
Create and modify product design specifications
Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures
Understand relevant security, privacy, and compliance principles and adhere to applicable regulations, standards, and procedures
Ensure other members of the department follow the QMS, regulations, standards, and procedures
Perform other work-related duties as assigned
Manage product development projects
Develop and maintain manufacturing processes
Lead and train staff
Ensure product quality and cost effectiveness
Ensure compliance with quality standards

Skills

Manufacturing Engineering

Process Development

Quality Systems

Design for Manufacturability

Engineering Drawings

Vendor Management

Cross-functional Leadership

Staff Management

R&D Transfer

Scale-up

Technology Integration

Lab Notebooks

Engineering Protocols

Penumbra Inc

Develops medical devices for vascular conditions

About Penumbra Inc

Penumbra Inc. specializes in creating medical devices aimed at treating neurovascular and peripheral vascular conditions. Their products, such as the Penumbra System and the Indigo System, are designed for use in hospitals and clinics, helping healthcare professionals address issues like stroke and other vascular diseases. These devices work by providing advanced tools for interventions in neurology and vascular surgery, allowing for effective treatment options. Unlike many competitors, Penumbra focuses specifically on these specialized areas, ensuring their products are tailored to the needs of medical professionals in these fields. The company's goal is to continuously improve and innovate their medical devices to enhance patient care and support healthcare providers in delivering effective treatments.

Alameda, CaliforniaHeadquarters

2004Year Founded

$116.7KTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees