Manufacturing Engineer II (Medical Device | 13485 | Metals)

Penumbra, Inc.; San Francisco (CA); On-site; USD 95,000 - 127,000; Full time

Benefits offered by this job

Medical coverage

Dental

Vision

401(k) with employer match

Parental leave

Paid vacation and holidays

Job summary

Penumbra, Inc. in Alameda, CA is seeking an engineering professional to independently perform detailed duties across product and process development.

You will solve complex problems, perform root cause analysis, and communicate solutions cross-functionally while supporting production and documentation in a qMS-regulated environment. The role emphasizes designing fixtures, qualifying equipment, and coordinating with suppliers to implement process improvements, with on-site work and potential

Qualifications

• Engineering degree with 1+ years of relevant engineering experience or equivalent
• Manufacturing environment experience preferred in medical device industry
• Strong written, verbal and interpersonal communication skills
• Proficiency in MS Word, Excel, PowerPoint, Access and related tools

Responsibilities

• Solve complex problems and implement innovative solutions.
• Perform root cause analysis and recommend vetted solutions.
• Communicate problems and solutions cross-functionally.
• Design fixtures and assist equipment qualification on production lines.
• Test processes, materials, and products; write test reports and conclusions.
• Plan and coordinate engineering work phases of projects.
• Develop product/process/equipment specifications.
• Coordinate with suppliers and external resources for process improvements.
• Train assemblers and technicians on processes and documentation.
• Adhere to QMS and applicable regulatory standards.

Skills

Complex problem solving

Root cause analysis

Cross-functional communication

Detail-oriented

Independent project recommendations

Production support

Documentation

Quality systems awareness

Process improvement

Education

Bachelor’s degree in Mechanical / Biomedical / Electrical / Chemical / Materials / Industrial Engineering or related field

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 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. *
• Approach problems from a detail-oriented perspective. *
• Suggest independent recommendations for project approaches, 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 fixtures on the production line. Perform equipment qualifications. *
• Test processes, equipment, raw materials, and products. 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 1+ years relevant engineering experience, or an equivalent combination of education and experience

• 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

Location:

Alameda, CA

Salary:

$95,000 to $127,000

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).

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.