Manufacturing Engineer I - Metals

Penumbra, Inc.; Roseville (CA); Sur place; USD 72 000 - 94 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Dental insurance

Vision insurance

Life insurance

AD&D insurance

Disability insurance

401(k) with employer match

Paid parental leave

11 holidays per year

15 days paid vacation per year

Paid sick time

Résumé du poste

Penumbra, Inc. in Roseville, CA, is seeking a Manufacturing Engineer to drive manufacturing technology, improve production yield, and support quality systems across the production floor.

You will resolve production issues, design fixtures, run process validations, and train staff while aligning with QMS and FDA-related standards. The role requires a bachelor’s degree in engineering and preferred 1+ year of manufacturing experience, with strong communication skills and proficiency in common

Qualifications

• Bachelor’s degree in Mechanical, Biomedical, Electrical, Chemical, Materials, or Industrial Engineering or related degree.
• 1+ year engineering experience in manufacturing preferred.
• Experience in the medical device industry preferred.
• Excellent written, verbal and interpersonal communication skills.
• Knowledge of FDA regulations, Lean/Flow Manufacturing, and materials/manufacturing processes desired.
• Proficiency in Word, Excel, PowerPoint, Access and other computer applications required.

Responsabilités

• Solve problems and implement innovative solutions on the production line.
• Execute root cause analysis and recommend vetted solutions.
• Communicate problems and solutions cross-functionally.
• Improve yield, efficiency, and throughput through process improvements.
• Design fixtures, acquire tooling, and implement new fixturing; perform equipment qualifications.
• Test processes, equipment, materials, and product; perform process validations and write reports.
• Plan and coordinate detailed phases of engineering work on projects.
• Develop specifications for products, processes, or equipment.
• Characterize and optimize processes using statistical techniques.
• Coordinate with suppliers and resources for process improvement plans.
• Train assemblers, QA and technicians on processes, equipment and documentation.
• Adhere to QMS and applicable quality regulations and procedures.
• Follow security, privacy and compliance principles.
• Perform other duties as assigned.

Description du poste

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 and across the business. Evaluates, selects, and applies exciting engineering techniques, procedures, and criteria, using judgment in developing and implementing adaptations and modifications on the production line and to quality systems.

Specific Duties and Responsibilities

• Solve 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. *
• 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. *
• 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 and 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. *
• 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, or an equivalent combination of education and experience

Additional qualifications:

• 1+ year relevant engineering experience preferred
• 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

Annual Base Salary: $72,000 to $94,000

Location: Roseville, CA

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.
• 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.
• Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.

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.

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.