Engineer, Design Assurance

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

Title: Engineer, Design Assurance

Location: Plymouth, MN

Duration: 12 Months

100% Onsite

Summary

A Design Assurance Engineer works closely with development/manufacturing/quality engineering to ensure compliance with the quality system. You will work closely with Regulatory Affairs personnel (internal or external) to monitor regulatory compliance.

You will monitor quality assurance efforts to ensure that the companys products conform to quality standards. You will partner with research/development and manufacturing engineering during new product start-ups and establishes checkpoints for testing new products and processes. The design assurance engineer is responsible for following established GMP/ISO compliant quality system practices.

Essential Functions

• Ensure companys 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.
• Aide in definition of test equipment as required to accomplish quality responsibilities.
• 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.
• Aide in definition of supplier quality specifications, sampling plans, and vendor qualification.
• Assist in specifications and testing of sterilization methods.
• Lead system and product continuous improvement teams.
• Reviews Engineering Change Orders, as required.
• Perform other duties and responsibilities as assigned by senior management.

Skills

• Must be able to identify failure modes based on function and design of medical devices
• Must have written and executed design validation protocols.
• Must be able to apply statistics to determine sample size and analyze data.

Consultants Eligible Benefits Upon Waiting Period

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.