Sr. Design Quality Engineer

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 management and lean sigma methodologies, including Define, Measure, Analyze, Improve, and Control (DMAIC) and 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.

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