Principal Manufacturing Engineer (Electronics)

General Summary

The mission of the Manufacturing Engineering group is to provide manufacturing technology and robust solutions that commercialize new products and that support continuous improvement in production.  Project opportunities are designed to develop professional work knowledge and abilities and to support the efforts and projects that have global importance to the success of the business.  Area of work involves manufacturing processes with interaction between production and cross-departmental engineering groups in resolving problems encountered on the production floor. Evaluates, selects, and applies exciting engineering techniques, procedures, and criteria, using judgment in developing and implementing adaptations and modifications on the production line.

This position is reserved for principal engineer personnel with outstanding scientific, technical, and/or quality system knowledge. Provide leadership in the engineering, design, and development of new products or changes to existing products, processes, and equipment. Interface and furnish knowledge to multi-disciplinary team overseeing development of Penumbra’s technology. Provide engineering support on existing devices for manufacturing. Develop, configure, and troubleshoot processing and associated equipment.  Research, identify, and evaluate automated processing equipment. Specify fixtures/tooling for automated equipment support.

Specific Duties and Responsibilities

As identified independently and/or assigned by a project team leader or a manager or as business needs dictate, independently perform any of the following:

•       Solve complex problems and implement innovative solutions.*

•       Fluently navigate quality system situations within and beyond scope and develop new aspects of the quality system independently. *

•       Manage projects as a Project Leader within a multidisciplinary project team of leaders independently.  Lead cross-functional company leaders with minimal guidance. *

•       Execute tasks independently and does not require assistance nor guidance.  Recommend vetted solutions proficiently and generate unique projects independently. *

•       Execute detailed root cause analysis and recommend vetted solutions.*

•       Communicate and explain problems and solutions cross-functionally and interdepartmentally.*

•       Think strategically within and beyond scope. *

•       Approach problems from a detail-oriented perspective.*

•       Suggest independent recommendations for project approach, scope, and tactics.*

•       Support production; creating and maintaining product and process documentation; monitor process and equipment performance and identify and implement process improvement activities to increase/optimize yield, efficiency, and/or throughput.*

•       Demonstrate an understanding of quality, operational, and financial systems, company products and customer requirements and how the product or project impacts the objectives of the business. Demonstrate an understanding of how other functional groups within the company are impacted by projects at hand and can impact the project or product results.

•       Design fixtures, acquire off-the-shelf tooling and equipment, and implement new fixturing on the production line. Perform equipment qualifications.*

•       Test processes, equipment, raw materials, and product.  Perform process validations.  Author protocols to execute tests, write reports and make conclusions and/or recommendations based on test results *

•       Plan, schedule, conduct, and coordinate detailed phases of engineering work as part of a project or as a total project. *

•       Develop specifications of a product, process, or piece of equipment.*

•       Develop, characterize, and optimize processes using statistical techniques and engineering knowledge and experience.*

•       Coordinate with the appropriate suppliers and other external resources needed in developing and implementing process improvement plans.*

•       Participate in project planning and scheduling.*

•       Train assemblers, quality control and technicians, as necessary, on processes, equipment, and documentation.*

•       Perform other activities requiring knowledge of principles and techniques commonly employed in the specific area of projects.

•       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

Location and Pay:

Alameda, CA

$150,000 to $195,000

Position Qualifications

Minimum education and experience:

• Bachelor’s degree in Engineering, Physical Sciences or a related technical field with 6+ years of engineering experience in the medical device industry, or equivalent combination of education and experience

Additional qualifications:

•       Deep understanding and experience with Electronic products

•       Ability to fully understand complex manufacturing processes of vast Electronic Bill of Materials including but not limited to: PCBAs, Solenoids, Injection Molding, Machining.

•       Ability to develop novel complex electronics manufacturing test solutions.

•       Experience managing outsourced supplier processes.

•       Engineering experience in a manufacturing environment recommended, medical device industry preferred

•       Excellent written, verbal and interpersonal communication skills required

•       Knowledge of FDA regulations, GMP/Quality System Regulations, Lean/Flow Manufacturing, and/or materials and manufacturing processes desired

•       Proficiency in Word, Excel, PowerPoint, Access, Altium, and other computer applications required 

Working Conditions

•    General office, production, laboratories and controlled environment facility

•    Business travel from 0% - 25% 

•    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.

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, an employee stock purchase plan, 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).

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.

If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.

For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.