Development Manufacturing Engineer I

Alameda, CAfull timeOn Site

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entry

$80k–$105k

H1B: no

Penumbrainc Development Manufacturing Engineer I at Penumbrainc supports manufacturing technology and continuous improvement by solving production problems and implementing engineering solutions. Engages in process validation, equipment qualification, and cross-functional communication.

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 fixtures on the production line. Perform equipment qualifications. *
Test processes, equipment, raw materials, and products. 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. *

Qualification

Bachelor’s degree in MechanicalExcellent writtenKnowledge of FDA regulationsProficiency in WordGeneral officeWillingness and ability to work on siteLocation and SalaryAnnual Base Salary Range

Required

Perform other work-related duties as assigned.
Bachelor’s degree in Mechanical, Biomedical, Electrical, Chemical, Materials, or Industrial Engineering or related degree, or an equivalent combination of education and experience
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
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.