Sr. Manufacturing Engineer, Operations Systems

Penumbra•Alameda, CA

About The Position

The Sr. Manufacturing Engineer, Operations Systems provides leadership in the engineering, design, and development of new products or changes to existing products, processes, and equipment. This role interfaces with and furnishes scientific knowledge to multi-disciplinary teams overseeing the development of neurovascular devices. The position also provides engineering support for existing devices in manufacturing. The area of work involves manufacturing and business processes with interaction between production, cross-departmental engineering groups, and other cross-functional teams (such as Regulatory, Quality, R&D, Supply Chain, IT, etc.) in executing and coordinating business operations systems projects and activities. Essential job functions include creating and executing an integrated cross-functional project plan.

Requirements

Bachelor’s degree in Mechanical, Biomedical, Electrical, Chemical, Materials, or Industrial Engineering or related degree and 4+ years relevant engineering experience, or an equivalent combination of education and experience
Proficiency in Word, Excel, PowerPoint, Access, and other computer applications required
High degree of accuracy and attention to detail
Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously

Nice To Haves

Master’s degree preferred
Detailed knowledge of GMP/Quality System Regulations and clean room environment practices
Demonstrated knowledge of engineering and scientific principles
Engineering experience in a manufacturing environment recommended, medical device industry preferred
Excellent written, verbal and interpersonal communication skills required
Knowledge of FDA regulations, Lean/Flow Manufacturing, and/or materials and manufacturing processes desired

Responsibilities

Develop new processes for medical devices and components
Execute tasks independently and does not require assistance nor guidance. Recommends vetted solutions independently.
Effectively and succinctly communicate task or activity status, assumptions, risks, timeline, and escalations cross-functionally and interdepartmentally, as required.
Lead cross-functional team to plan and implement changes and improvements to operational systems and processes, with knowledge and consideration towards requirements and inputs from cross-functional teams and key stakeholders.
Lead identification, discussion, and mitigation of project risks to successful completion of tasks and activities, appropriately escalating issues to management or leadership, as required.
Lead cross-functional discussion of project performance and drives project issue resolution.
Provide direction on requirements to meet internal and external stakeholder expectations.
Create drawings for Production and Research and Development
Manage projects as a Project Leader within a multidisciplinary project team of peers independently. Leads other engineers independently. Influences other departments with guidance.
Provide technical support and perform tasks within multidisciplinary project team
Document manufacturing and production development process through lab notebooks, engineering protocols, and engineering reports
Identify and utilize vendors in the development of processes for Penumbra, Inc. products
Perform research and integrate new technologies into existing and future products and processes
Evaluate and troubleshoot problems to assess root cause and corrective action
Interpret and communicate test results
Solve practical problems encountered
Document findings and recommendations
Create and modify product design specifications
If in a supervisory position, select, manage, train, and develop staff. Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans.
Provide guidance and review for less experienced team members, or cross-functional teams. May assist in onboarding.
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 the regulations, standards, and procedures that are applicable to the Company.
Ensure other members of the department follow the QMS, regulations, standards, and procedures.
Perform other work-related duties as assigned.