Product Quality Engineer (Local candidates only)

Centese; Omaha (NE); On-site; USD 70,000 - 90,000; Full time

Job summary

A medical device startup is seeking a Product Quality Engineer to lead post-market investigations and risk-based improvements. The role involves collaborating with Quality, Manufacturing, and R&D teams to resolve product issues and requires strong mechanical engineering skills. Ideal candidates will hold a Bachelor's degree in Mechanical or Biomedical Engineering and have at least 3 years of relevant experience. The position is located in Omaha, NE, and relocation is not provided.

Qualifications

• 3+ years of experience in product quality engineering or manufacturing engineering.
• Strong knowledge of FDA and ISO regulations.
• Ability to manage multiple projects in a fast-paced environment.

Responsibilities

• Lead investigations into product non-conformance issues.
• Document findings from root-cause analysis.
• Collaborate with teams to resolve issues efficiently.

Skills

Non-conformance management

Root cause analysis

Corrective action techniques

Problem-solving

Communication skills

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Tools

MathWorks MATLAB

Job description

Product Quality Engineer (Local candidates only)

Centese, Inc. is a fast-paced start‑up medical device company developing products to improve outcomes for patients undergoing heart and lung surgery. The first product, Thoraguard, is a fully automated chest tube and chest drainage system at the intersection of patient‑centric outcome improvement and digital medicine. We are building a team of multidisciplinary experts passionate about positively impacting the lives of others through technological advancement.

SUMMARY OF POSITION

As a Product Quality Engineer, you will serve as the technical lead for post‑market product investigations, root cause analysis, and risk‑based product improvements. This role partners closely with Quality to support nonconformance, CAPA, and complaint activities by providing the engineering analysis, technical judgment, and corrective action development needed to resolve product and process issues. The position requires strong mechanical and manufacturing engineering skills, along with working knowledge of quality and regulatory requirements—preferably in a medical device environment.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Lead investigations into product non‑conformance issues, determining root causes, and developing corrective and preventive actions (CAPA)
• Monitor product performance data to identify trends and proactively address potential issues
• Document and report findings from root‑cause analysis, ensuring compliance with regulatory standards
• Collaborate with cross‑functional teams including Quality, Manufacturing, and R&D to ensure issues are resolved efficiently and effectively
• Lead longer‑term effort to improve design for manufacturability and design for assembly for disposable kits & control module
• Assist in maintaining and improving the quality management system, ensuring ongoing compliance with FDA and ISO standards
• Support design changes, alternate supplier qualification, and process improvements to enhance product cost, reliability and manufacturability
• Participate in the review and update of design control documents, including Design History Files (DHF) and Device Master Records (DMR)
• Provide technical support to the Clinical Specialists team for escalated product issues
• Stay updated on industry trends and emerging technologies that could impact the product lifecycle

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

• Bachelor's degree in Mechanical or Biomedical Engineering
• 3+ years of experience in product quality engineering, sustaining engineering, or manufacturing engineering
• Strong knowledge of non‑conformance management, root cause analysis, and corrective action techniques
• Familiarity with FDA and ISO regulations
• Excellent problem‑solving skills with a data‑driven approach
• Strong communication skills, both written and verbal, with the ability to work collaboratively in a fast‑paced start‑up environment
• Ability to manage multiple projects and prioritize tasks effectively
• Familiarity with MathWorks MATLAB for engineering investigation data analysis; plotting and interpreting multi‑variable datasets
• Authorized to work in the United States without additional visa sponsorship

PREFERRED KNOWLEDGE, SKILLS, AND ABILITIES

• Experience in the medical device industry and ISO 13485
• Experience with injection molding, extrusion, or other plastic manufacturing methods
• Experience with CAPA processes in a regulated industry
• Familiarity with formal risk management tools and techniques
• Experience with quality management systems (QMS) software
• Understanding of human factors engineering and usability principles

LOCATION

Must be located in the Omaha, NE or surrounding areas; relocation is not provided.

BENEFITS AND REQUIREMENTS

MUST PASS A CRIMINAL BACKGROUND CHECK.

APPLICATION DETAILS

• Seniority level: Mid‑Senior level
• Employment type: Full‑time
• Job function: Quality Assurance
• Industries: Medical Equipment Manufacturing