Development Manufacturing Engineer III - Electronics

Penumbra, Inc.; San Francisco (CA); On-site; USD 109,000 - 152,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) match

Parental leave

Company holidays

Vacation

Job summary

Penumbra, Inc. in Alameda, CA is seeking an engineer to join our team, executing detailed projects in a manufacturing environment.

You will analyze complex problems, perform root cause analysis, and coordinate cross-functional efforts to deliver innovative solutions. The role involves leading supplier-level project implementations, developing processes and fixtures, and ensuring compliance with QMS and FDA-related requirements.

Qualifications

• Engineering degree with 2+ years relevant experience in manufacturing.
• Experience in medical device manufacturing preferred.
• Familiarity with FDA regulations and Lean/Flow Manufacturing.
• Proficient in MS Office applications.

Responsibilities

• Solve complex problems and implement innovative solutions.
• Perform root cause analysis and propose vetted solutions.
• Communicate problems and solutions cross-functionally.
• Lead supplier-level project implementations and track milestones.
• Develop and validate processes and equipment; document results.
• Adhere to QMS and related quality standards.

Skills

Complex problem solving

Root cause analysis

Cross-functional communication

Project coordination

Quality systems knowledge

Education

Bachelor's degree in Mechanical, Biomedical, Electrical, Chemical, Materials, or Industrial Engineering

Tools

Word

Excel

PowerPoint

Access

Job description

Specific Duties and Responsibilities

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

• Solve complex problems and implement innovative solutions. *
• Execute detailed root cause analysis and recommend vetted solutions. *
• Communicate and explain problems and solutions cross- functionally and interdepartmentally. *
• Collaborate closely with suppliers, ensure timely, communication of updates, and respectfully request any necessary changes.*
• Engage in the troubleshooting of electromechanical products by employing failure analysis and problem-solving techniques, while also recommending and implementing effective solutions.*
• Lead the implementation of projects at the supplier level, managing communications related to test plans, monitoring project timelines, and ensuring all milestones are met efficiently.*
• 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
• 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 Qualifications

Minimum education and experience:

• Bachelor's degree in Mechanical, Biomedical, Electrical, Chemical, Materials, or Industrial Engineering or related degree with 2+ years relevant engineering experience, or an equivalent combination of education and experience
• Engineering experience in a manufacturing environment recommended, medical device industry preferred
• Experience with Electronic devices and or PCBAs
• Experience with Contract Manufactured Electromechanical Medical device products
• Excellent written, verbal, and interpersonal communication skills required; leadership skills desired
• 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

Location and Salary

Alameda, CA

Annual Base Salary Range: $109,000 to $152,000

We offer a competitive compensation package plus a benefits and equity program, when applicable.

Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

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).

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.