Onsite Design Assurance Engineer – Medical Devices (GMP/ISO)

Abbott; Plymouth (MN); On-site; USD 55,000 - 83,000; Full time

Benefits offered by this job

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account (HSA)

Flexible Spending Accounts

Supplemental Life Insurance

Short Term Disability

Long Term Disability

401(k)

Job summary

Abbott is seeking a Design Assurance Engineer in Plymouth, MN to ensure GMP/ISO compliant quality systems and collaborate with development, manufacturing, and regulatory affairs.

You will lead design assurance activities for electromechanical systems, manage Design History Files, define test plans, perform validation and verification, and drive risk analysis, investigations, and continuous improvement within a 12-month onsite engagement.

Qualifications

• Experience identifying failure modes in medical device design.
• Experience writing and executing design validation protocols.
• Ability to apply statistics to determine sample sizes and analyze data.

Responsibilities

• Ensure company adherence to the established Quality System and GMP/ISO standards, including ongoing establishment and improvement to the quality system procedures.
• Lead design assurance activities in support of development for electromechanical systems that utilize microcontroller technology, customized/off the shelf PCBs and software applications.
• Manage new product Design History Files.
• Work with Engineering, Marketing, Manufacturing and Regulatory to establish measurable, valid product requirements.
• Develops and documents test plan protocols, test procedures, and test reports.
• Perform tests according to various protocol requirements.
• Lead completion of risk management and risk analysis including FMEA.
• Devise design verification and design validation plans for products based on performance specifications and risk analysis
• Analyze and communicate conformance to specifications and standards.
• Conducts technical and statistical investigations concerning compliance to specification and optimization of design relevant to specification.
• Support completion of in vitro testing including applicable animal studies.
• Lead system and product continuous improvement teams.
• Reviews Engineering Change Orders, as required.

Skills

Identify failure modes

Design validation protocols

Statistics for sample size

Job description

Abbott is seeking a Design Assurance Engineer in Plymouth, MN to ensure GMP/ISO compliant quality systems and collaborate with development, manufacturing, and regulatory affairs.

You will lead design assurance activities for electromechanical systems, manage Design History Files, define test plans, perform validation and verification, and drive risk analysis, investigations, and continuous improvement within a 12-month onsite engagement.