Lead Quality Engineer – Medical Device Development

Penumbrainc; Alameda (CA); On-site; USD 125,000 - 175,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

AD&D

Disability insurance (short/long-term)

401(k) with employer match

Paid parental leave

Company holidays

Vacation accrual

Paid sick time

Job summary

Penumbra, Inc. in Alameda, CA seeks a Senior Development Quality Engineer to lead quality engineering for new and existing products within a development team.

You will design and implement quality controls, participate in audits, and ensure design control requirements are met across design, manufacturing, and testing processes. The role requires a 5+ year engineering background (Bachelor’s or higher) with experience in medical/dev/regulatory environments, excellent communication, and strong

Qualifications

• Bachelor’s degree in Engineering, a Life Science or related field with 5+ years or relevant experience.
• Advanced degree preferred.
• Experience in auditing, design review, sterilization, project management, and/or product development highly desired.
• Demonstrated knowledge of engineering and scientific principles.
• High proficiency with computers and software applications.
• Medical device, pharmaceutical, biotech, and/or other regulated industry experience desired.
• Strong oral, written, and interpersonal communication skills.
• High degree of accuracy and attention to detail.
• Excellent organizational skills with ability to prioritize while handling multiple projects.

Responsibilities

• Lead in development and qualification activities for new and existing products.
• Lead and participate in project teams coordinating quality efforts across design, development, and improvements.
• Design and implement methods for inspecting, testing, and evaluating equipment accuracy.
• Develop and validate measurement methods.
• Monitor design control to meet guidelines and regulatory standards.
• Support developmental projects in quality engineering.
• Analyze reports and recommend corrective actions.
• Perform statistical analysis on non-conforming materials or products.
• Assist during FDA inspections and audits.
• Develop and approve documentation for inspection/testing procedures.

Skills

Auditing experience

Design review

Sterilization

Project management

Product development

Communication skills

Regulatory industry experience

Education

Bachelor’s degree in Engineering or related field

Advanced degree preferred

Tools

MS Word

Excel

PowerPoint

Job description

Penumbra, Inc. in Alameda, CA seeks a Senior Development Quality Engineer to lead quality engineering for new and existing products within a development team.

You will design and implement quality controls, participate in audits, and ensure design control requirements are met across design, manufacturing, and testing processes. The role requires a 5+ year engineering background (Bachelor’s or higher) with experience in medical/dev/regulatory environments, excellent communication, and strong