Engineer II, QA Design – Sustaining
Artex Risk Solutions
full-time
Posted on:
Location Type: Office
Location: Naples • Florida • 🇺🇸 United States
Visit company websiteJob Level
JuniorMid-Level
About the role
- Support Design Quality Engineering efforts on product sustainability of released products to the market.
- Review production specifications, when requested by manufacturing, to clarify requirements, establish practical inspection methodologies, and/or improve product requirements for the overall manufacturability of products with the support of Design Engineering and manufacturing facilities.
- Ensure Essential Design Outputs remain under appropriate manufacturing process control throughout the product lifecycle.
- Perform root cause investigation as part of improving product quality/performance issues as a result of design failure modes stemming from product design and/or manufacturing process.
- Maintains understanding and regulations/standards from product release through product retirement, acting as a resource to other functional groups, within the product design change process.
- Support product risk assessment activities through application of a working knowledge of applicable standards (e.g., ISO14971, etc.) and tools such as (application, design, process) FMEAs, FTA, and Hazard Assessment.
- Lead the enhancement and continuous improvement of the Risk Management processes for medical devices, including the creation, oversight, and global harmonization of policies and procedures.
- Display working knowledge in the area of usability/human factors engineering principles including standards (IEC 62366) and FDA guidance for compliance.
- Facilitate the planning, execution, and review of verification/validation (v&v) activities including assessment of adequate inputs to the v&v process.
- Provide direction on how to perform Test Method Validations, where appropriate, leads efforts to reduce test method bias ensuring a robust accept/reject process.
- It could require training of manufacturing personnel in appropriate test procedures, inspection methods, and interpretation of results.
- Provide statistical techniques for appropriate product testing strategies in alignment to risk levels estimated from the Risk Management process.
- Support NCRs and CAPAs related to design and/or inspection/test methods.
Requirements
- Bachelor’s degree in Engineering required; Biomedical, Mechanical, or Electrical Engineering degree preferred
- 2+ years design assurance / quality assurance experience in a medical device or other highly regulated industry required
- Working knowledge of ISO and FDA design and development quality requirements
- Technical and working knowledge in Six Sigma and Lean methodologies
- Proficiency in assessing manufacturing quality requirements
- Technical knowledge in development methodologies, and project implementation, including but not limited to, GD&T & DOE preferred
- Proficiency with PC operations, and the Microsoft Office suite, and CAD/CAM Software
- Hands on experience with SAP and Agile preferred
Benefits
- Medical, Dental and Vision Insurance
- Company-Provided Life Insurance
- Voluntary Life Insurance
- Flexible Spending Account (FSA)
- Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
- Matching 401(k) Retirement Plan
- Annual Bonus
- Wellness Incentive Program
- Free Onsite Medical Clinics
- Free Onsite Lunch
- Tuition Reimbursement Program
- Trip of a Lifetime
- Paid Parental Leave
- Paid Time Off
- Volunteer PTO
- Employee Assistance Provider (EAP)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
design assurancequality assuranceroot cause investigationrisk assessmentusability engineeringverification validationtest method validationstatistical techniquesGD&TDOE
Soft skills
leadershipcommunicationcollaborationproblem-solvingtraining