General SummaryThe Sr. Manufacturing Engineer 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. Develop, configure, and troubleshoot processing and test equipment. Research, identify and evaluate automated processing equipment. Specify fixtures/tooling for automated equipment support.
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. *
- 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 *
- 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 *
- 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.
- 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
Position QualificationsMinimum education and experience:
- Bachelor's degree in engineering or related technical field with 4+ years of engineering level experience, preferably in the medical device industry, 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
- High proficiency with computers and software applications
Location: Alameda, CA
Salary: $125,000 to $175,000
Working Conditions- General office, laboratory, and clean room environments.
- Willingness and ability to work on site.
- Business travel from 0% - 10%
- Potential exposure to blood-borne pathogens.
- Requires some lifting and moving of up to 25 pounds.
- Must be able to move between buildings and floors.
- Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.
- Must be able to read, prepare emails, and produce documents and spreadsheets.
- Must be able to move within the office and access file cabinets or supplies, as needed.
What We Offer• A collaborative teamwork environment where learning is constant, and performance is rewarded.
• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
• A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).
