Sr Manufacturing Engineer

Penumbra, Inc.; Roseville (CA); On-site; USD 113,000 - 157,000; Full time

Benefits offered by this job

Healthcare benefits

401(k) with employer match

Paid holidays and vacation

Job summary

Penumbra, Inc. seeks a Senior Manufacturing Engineer to lead design and development of new products and changes to existing processes. You will oversee manufacturing support, troubleshoot equipment, and drive automation and improvements in a regulated medical-device environment.

You will create production drawings, lead multidisciplinary projects, and ensure QMS compliance. On-site work in California with travel up to 10% may be required; a strong background in GMP and clean-room practices is

Qualifications

• Bachelor’s degree in engineering or related technical field with 4+ years of engineering experience
• 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

Responsibilities

• Create drawings for Production and Research and Development
• Manage projects as a Project Leader within a multidisciplinary project team
• Provide technical support within multidisciplinary project team
• Document manufacturing and production development process through lab notebooks, engineering protocols, and reports
• Identify and utilize vendors in the development of processes
• Train engineers, technicians and assemblers in new processes and methods
• Adhere to the Company’s Quality Management System (QMS) and regulations

Skills

GMP knowledge

Engineering principles

Computer proficiency

Medical device experience

Education

Bachelor's degree in engineering

Master's degree preferred

Job description

General Summary

The 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.
• 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 Qualifications

Minimum 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

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 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.

Annual Base Salary Range: $113,000 - $157,000

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.

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 toPenumbra's Privacy Notice for California Residents.

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