Sr. Design Quality Engineer

Regulatory Toolkit; Memphis (TN); In loco; USD 115.000 - 148.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health Insurance

Dental and vision insurance

Health Savings Account

Healthcare Flexible Spending Account

Life insurance

Long-term disability leave

Dependent daycare spending account

Tuition assistance/reimbursement

Simple Steps (global well-being plan)

Incentive plans

401(k) with employer match

Short-term disability

Paid time off

Paid holidays

Employee Stock Purchase Plan

Employee Assistance Program

Non-qualified Retirement Plan Support

Capital Accumulation Plan

Descrizione del lavoro

Regulatory Jobs in Memphis, TN seeks an experienced engineer to develop and evaluate medical device designs optimized for manufacturability, reliability, and cost. You will verify design functionality, apply DMAIC and DRM, and ensure FDA/ISO regulatory compliance across design, testing, and documentation.

Responsibilities include risk assessment with FMEA, QMS processes, CAPA/RCA, and maintaining PSURs, CERs, and TD files per EU MDR and global requirements.

Competenze

• Requires a Master’s degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field.
• Minimum 2 years of experience as a quality, product or validation engineer.
• Experience with DMAIC, FMEA, ISO 14971, FDA 21 CFR Part 820, ISO 13485, GDP.
• Strong knowledge of QMS, CTQ, and GMP requirements.
• Proficiency with Minitab, DOE, SPC, ANOVA, t-tests, regression analysis, and process capability.
• Familiarity with CAPA, RCA, IQ/OQ/PQ, PSUR, CER, and EU MDR.
• Experience with PPAP, CP, PF, and MR for transfer projects.

Mansioni

• Develop and evaluate designs meeting medical device requirements and manufacturability goals.
• Verify design functionality with test method development and specifications.
• Apply DMAIC, DRM, and lean tools in line with FDA regulations and ISO standards.
• Collaborate with cross‑functional teams to maintain regulatory documentation.
• Lead CAPA and RCA activities to prevent recurrence and document resolutions.
• Prepare PSURs, CERs, and TD files per EU MDR and global requirements.

Conoscenze

DMAIC methodology

Minitab

DOE

SPC

Gage R&R

ANOVA

T-test

Regression analysis

Process capability

Confidence & tolerance

FMEA

A3 thinking

PDCA

Ishikawa

QMS

CTQ

FDA 21 CFR 820

ISO 13485

GDP

IQ/OQ/PQ

CAPA

RCA

PSUR

CER

TD files

PPAP

CP

PF

MR

Formazione

Master's degree in Mechanical/Industrial/Biomedical Engineering

Descrizione del lavoro

We anticipate the application window for this opening will close on - 25 Nov 2026

Position Description:

Develop and evaluate designs which meet defined medical device product requirements and that are optimized for manufacturability, reliability, and overall cost to the business. Verify the functionality of product design by developing design test methodology and specifications to ensure product designs meet applicable performance requirements. Utilize project mgmt. and lean sigma methodologies, including Define, Measure, Analyze, Improve, and Control (DMAIC) & Design for Reliability and Manufacturability (DRM), MS Project and adhere to the applicable medical device FDA requirements for design and manufacturing, including medical device materials and related processes. Utilize design development, analysis and statistical tools including Minitab, and statistical methods including DOE (Design of Experiments), SPC (Statistical Process Control), Variable Gage R & R (Reliability and Repeatability), ANOVA (analysis of Variance), t-test, regression analysis, Process Capability, and Confidence & Tolerance interval analysis. Evaluate products and process risks using Failure Mode Effects Analysis (FMEA), utilizing ISO14971. Conduct QMS (Quality Mgmt. System) processes including CTQ (Critical to Quality) identification and leverage knowledge of FDA 21 CFR part 820, ISO 13485 and Good Documentation Practices (GDP). Utilize Lean sigma, including design capability, value stream and process mapping, and 5S. Troubleshoot production and other issues utilizing problem solving techniques, including A3 thinking, PDCA (Plan, Do, Check, Act), 5 Why’s and Ishikawa (Fishbone). Execute Process Qualification including IQ (Installation Qualification), OQ (operation Qualification) and PQ (Performance Qualification) and perform safely. Leverage Corrective and Preventive actions (CAPA) with use of RCA (Root Cause Analysis) to solve problems, document conditions and create solutions to avoid future problems. Responsible for developing, contributing to, and maintaining Periodic Safety Update Reports (PSURs), Clinical Evaluation Reports (CERs), and Technical Documentation (TD files) in accordance with EU MDR (Medical Device Regulations) requirements. Collaborate with cross functional teams to ensure compliance with global regulatory expectations, support lifecycle mgmt. activities, and maintain up to date clinical, safety, and technical documentation for assigned products. Comply with Production Part Approval Process (PPAP) requirements documentation, including Control Plans (CP), Process Flow (PF), and Material Requirements (MR) for transfer projects. Relocation assistance is not available for this position. #LI-DNI.

Basic Qualifications:

Requires a Master’s degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field and 2 years of experience as a quality, product or validation engineer.

Must possess at least two (2) years of experience with each of the following:

• DMAIC methodology;
• Minitab, DOE, SPC, Variable Gage R & R, ANOVA, t-test, regression analysis, Process Capability, and Confidence & Tolerance interval analysis;
• Product and Process risk utilizing FMEA and ISO 14971, A3 thinking, PDCA, 5 Why’s, and Ishikawa (Fishbone);
• QMS process, CTQ identification, FDA 21 CFR Part 820, ISO 13485, and GDP;
• IQ/OQ/PQ, CAPA and RCA;
• PSUR, CER and TD files as per EU MDR and global requirements;
• PPAP, CP, PF, MR for transfer projects.

Salary: $115,000 to $147,600 per year

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week:

• Health
• Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)

The following benefits and additional compensation are available to all regular employees:

• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans