Senior Manufacturing Engineer, Medical Devices

Lever, Inc.; Alameda (CA); On-site; USD 109,000 - 152,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Job summary

Penumbra, Inc. in Alameda, CA is seeking a Manufacturing Engineer to design, execute and document test plans for qualification of PCBA components, perform root cause analysis, and drive cross-functional improvements on the production floor.

You will lead supplier collaboration, manage NCRs and engineering change orders, apply QMS, and implement process improvements to boost yield and throughput. A Bachelor's in engineering with 4+ years in medical device manufacturing is required, along with

Qualifications

• Minimum: Bachelor’s degree in Electrical, Biomedical, Mechanical, Chemical, Materials or Industrial Engineering with 4+ years of experience.
• Experience in a manufacturing environment, medical device knowledge preferred.
• Excellent written, verbal and interpersonal communication; leadership skills desired.

Responsibilities

• Design, execute and document test plans for qualification of PCBA components.
• Execute root cause analysis and recommend vetted solutions.
• Communicate problems and solutions cross-functionally.
• Collaborate with suppliers and manage change orders within QMS.
• Lead supplier-level project implementations and monitor milestones.
• Support production with process documentation and improvements.

Skills

Communication skills

Leadership

FDA regulations knowledge

Lean manufacturing knowledge

Education

Bachelor's degree in Electrical, Biomedical, Mechanical, Chemical, Materials, or Industrial Engineering or related degree with 4+ years relevant engineering experience

Tools

Microsoft Office (Word, Excel, PowerPoint, Access)

Job description

Penumbra, Inc. in Alameda, CA is seeking a Manufacturing Engineer to design, execute and document test plans for qualification of PCBA components, perform root cause analysis, and drive cross-functional improvements on the production floor.

You will lead supplier collaboration, manage NCRs and engineering change orders, apply QMS, and implement process improvements to boost yield and throughput. A Bachelor's in engineering with 4+ years in medical device manufacturing is required, along with