General Summary
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. Interfaces with and furnishes scientific knowledge to multi-disciplinary teams overseeing development of neurovascular devices. Provide engineering support on existing devices for manufacturing. 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.
Specific Duties and Responsibilities
• Fluently navigate quality management systems within scope and have general knowledge of quality systems beyond scope. *
• Develop new processes for medical devices and components *
• Execute tasks independently and does not require assistance nor guidance. Recommends vetted solutions independently. *
• Thinks strategically within scope. *
• 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.*
• Provides 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.
*Indicates an essential function of the role
Starting Base Salary: $113,000 to $157,000 (based off state residing in)
Position Qualifications
Minimum education and experience:
• 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
Additional qualifications:
• 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
• 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
Working Conditions
• General office, laboratory, and cleanroom environments
• Potential exposure to blood-borne pathogens
• Requires some lifting and moving of up to 25 pounds
• The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods. Specific vision abilities required by this job include the ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.
