About the role

Aplyr's Quick Take

This role is about ensuring quality in the manufacturing of medical devices, focusing on problem-solving and process improvement. You'll work independently to tackle quality challenges, lead investigations, and collaborate with engineering teams to integrate quality into production. It's primarily an individual contributor role with some cross-functional interaction.

Good fit

Ideal candidates have at least 3 years of experience in Quality or Manufacturing Engineering within the medical device sector, with a strong background in problem-solving and data analysis. A proactive, detail-oriented approach and good communication skills are essential.

Worth noting

The role emphasizes autonomy and complex problem-solving, which may not suit everyone. The focus on Lean and Six Sigma methodologies suggests a fast-paced environment aimed at continuous improvement.

General Summary

As a Quality Engineer III, you will support manufacturing operations and production lines for a range of medical devices. This role requires you to tackle complex, ambiguous quality challenges in our manufacturing processes with a high degree of autonomy, applying advanced problem solving and thoughtful decision-making from early commercial ramp through mature production. Your work will directly impact patient safety and product performance, while influencing cross functional decisions, leading investigations, proactively identifying risk, and helping shape robust, scalable quality systems that support both innovation and compliance. You will partner closely with Manufacturing Engineering, Production, and Industrial Engineering to ensure quality is built into every stage of the manufacturing process.

Specific Duties and Responsibilities

• Provide Quality Engineering support for assigned products and production lines

• Act as a quality partner to Production, Manufacturing Engineering, and Industrial Engineering

• Lead root cause investigations using structured problem solving tools (5 Why, Fishbone, DOE, regression analysis)

• Support monitoring of manufacturing quality performance, including yield, scrap, and process capability

• Improve inspection strategies, including in process and final inspection, destructive testing, sampling plans, and acceptance criteria

• Lead continuous improvement of inspection systems, test methods, process monitoring, and other quality tools

• Apply Lean and Six Sigma methodologies to reduce waste and improve process capability

• Execute quality system activities within Operations, including NCRs, MRB, CAPAs, control chart investigations, and effectiveness verification

• Maintain pFMEAs, ensuring risks are mitigated through appropriate controls and monitoring

• Support early commercial ramp-up, material or process changes, and site transfers

Position Qualifications

Minimum education and experience:

• Bachelor’s degree in Engineering (Biomedical, Mechanical, Materials, Chemical, or related discipline preferred)

• 3+ years of experience in Quality Engineering or Manufacturing Engineering within the medical device industry

• Experience supporting manufacturing operations, process development, or NPI

• Strong problem solving, data analysis, and decision making skills

• Excellent verbal, written, and interpersonal communication skills

Preferred Experience:

• Familiarity with QSR, ISO, and other applicable regulations and laws

• Experience supporting high volume manufacturing and early commercial yield ramp

• Experience leading projects or coordinating cross functional project activities

• Background in inspection systems, destructive testing, and statistical sampling methodsVersatility, flexibility, and willingness to work within a dynamic environment

Working Conditions

• General office, laboratory, and cleanroom environments

• Requires some lifting and moving of up to 25 pounds

• The employee is frequently required to stand, walk, sit, and reach with hands and arms,

and to use a computer, sitting for extended periods. Specific vision abilities required by

this job includes the ability to read, close vision, distance vision, color vision, peripheral

vision, and depth perception.

• Alameda, CA

• Starting Base Salary is $109,000/year to $152,000/year

The above statements are intended to describe the general nature and level of work being

performed by people assigned to this classification. They are not intended to be construed as an

exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

Skills & Tags

aws ai data product

Aplyr's read

Penumbra Inc. is a pioneering medical device company, attracting professionals passionate about advancing vascular and neurovascular healthcare solutions.
Synthesized from recent postings & public sources

What's promising

•Strong focus on innovative medical devices for vascular and neurovascular treatments.
•Global presence offers diverse career opportunities across multiple regions.
•Recent hiring in specialized roles indicates growth and expansion in key markets.

What to watch

•Highly competitive medical device industry poses challenges for market share.
•Regulatory hurdles in healthcare can impact product rollout timelines.
•Dependence on innovation requires sustained investment in R&D.

Why Penumbra Inc

•Specializes in both vascular and neurovascular medical device solutions.
•Global reach with roles in diverse geographical locations such as Poland and the Netherlands.
•Commitment to cutting-edge technology in healthcare solutions.

Aplyr’s read is generated by AI from public sources. Was it useful?