Test Method Engineer Job at Pentangle Tech Services | P5 Group, Maple Grove, MN

STZBcFg5Z2JKWG1pSEFXTXNpYXB6TWNiNVE9PQ==
  • Pentangle Tech Services | P5 Group
  • Maple Grove, MN

Job Description

Job Description

We are seeking a skilled and detail-oriented Test Method Engineer with experience in the medical device industry to support the review and remediation of legacy test methods. This role is crucial in ensuring the adequacy and compliance of existing test protocols for devices such as tubes, bonds, sterility, and catheters, with a focus on fluid-based testing. The engineer will also be responsible for creating new test protocols utilizing product risk documentation.

Responsibilities

  • Review and assess legacy test methods, including leak pressure, Luer leak testing, label adhesion, Luer standard compliance, microsphere mass, tensile tubing bonds, and needle engagement.
  • Identify gaps, inconsistencies, and opportunities for improvement in existing methods.
  • Remediate test methods to meet current standards and best practices.
  • Evaluate and document the risk of changes to test methods, ensuring traceability and justification.
  • Collaborate with cross-functional teams including R&D, Quality, and Regulatory Affairs.
  • Ensure all updates align with applicable regulatory and industry standards.
  • Provide technical documentation and support for internal audits and reviews.

Essential Skills

  • Bachelor’s degree in Engineering or related field.
  • Minimum 4 years of experience in the medical device industry.
  • Strong understanding of test method development and remediation.
  • Familiarity with risk assessment methodologies (e.g., FMEA).
  • Excellent analytical, documentation, and communication skills.
  • Ability to work independently and onsite.
  • Experience with Class III Single Use Devices.
  • Experience with 21 CFR 820.30.

Additional Skills & Qualifications

  • Experience with ISO standards is highly desirable.
  • Experience with tubes, bonds, sterility, catheters, and fluid-based testing is highly desirable.
  • Experience with ISO and ASTM standards relevant to medical devices.
  • Knowledge of regulatory requirements (FDA, EU MDR).
  • Hands-on experience with lab equipment and test setups

Job Tags

Similar Jobs

4L Managed Accounting LLC

Accounts Payables Clerk Job at 4L Managed Accounting LLC

 ...offices in Tampa, FL, and Tucson, AZ, 4L works with law firms across the country. Our deep industry experience covers law firm financial, tax, ethical, and workflow issues, developed through years of managing midsize and large law firms. Qualifications Knowledge of... 

Cape Cod Healthcare

Quality & Patient Safety Advisor Job at Cape Cod Healthcare

 ...National Patient Safety Goals, Process and Systems Improvement, Public and Internal Reporting, and Peer Review facilitation. PRIMARY...  ...(BoRM), the Joint Commission (TJC), Department of Public Health (DPH). Maintains current knowledge of all Regulatory changes/... 

ARIZONA FOOT & ANKLE SPECIALISTS, LLC

Podiatrist Job at ARIZONA FOOT & ANKLE SPECIALISTS, LLC

We at Arizona Foot & Ankle Specialists are not just a traditional podiatrist office. We strive to provide our patients with cutting edge top-of-the-line treatments to help them get back to whatever activities that they want to do in the fastest most efficient way possible...

Robert Half

Senior Financial Analyst Job at Robert Half

 ...The ideal candidate will be responsible for managing multiple financial analysis projects at the same time. At month end, you will be responsible for budget, projection, and actual variance commentary. Responsibilities Prepare the company's expense plans and monthly... 

Niche SSP - No.1 for Estimating Talent

Estimator Job at Niche SSP - No.1 for Estimating Talent

 ...Estimator | Richmond, VA | Up to $115K Client: A nationally recognized General Contractor known for delivering award-winning projects across the U.S. On Offer: Competitive salary and benefits package. Strong career development with clear growth opportunities...