Quality Engineer
This position supports process management for existing legacy products and risk management. This position is part of the R&D Product Engineering Team (MDR Project) whose responsibility is to support the EU MDR project timeline, including product remediation testing and label changes.
Responsibilities:
- Leads development of risk assessments and test methods
- Supports component qualifications, design validation / verification and process validation
- Ability to make and present risk-based decisions
- Assess process changes against process risk documents
- Supports translation of design inputs into manufacturing control plans
- Participate and provide input to training on department/division procedures, and policies
- Participate in project planning, budgeting, scheduling and tracking
- Develop and implement procedures to comply with corporate and industry standards
- Provide positive example and actively promote compliance to division, corporate and industry standards
- Maintain a professional working relationship with internal and external customer and support staff
- Prepare and present project updates and technical discussions
- Working knowledge of product use to manage user(s) impact with the ability to manage risk effectively
- Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)
- Working knowledge in some of the related business technologies
- Advanced statistical and risk assessment techniques
- Working knowledge of test method (development and validation), equipment qualifications, and design validation, risk assessment techniques, and component qualification methodologies
- Ability to write protocols for Gage R&R/ MSA studies, perform those studies and analyze results preferably using Minitab
- Working knowledge of blueprints, and GD&T
- Working knowledge of code level review, software logic review, black box testing, and system validation
- Ability to make and present risk-based decisions
- Strong interpersonal skills
- Ability to analyze and optimize manufacturing and quality systems
- Product, design & prototyping
- Ability to create and provide training
- Software application skills
- Problem solving ability
- Ability to create, review and coordinate test protocols and reports
- Ability to generate engineering proposals
- Oral and written presentation skills
- Ability to Lead cross functional teams
- Understanding of regulatory requirements
- Ability to create and/or update process mode failure effects analysis (pFMEA) and other related risk documents
Required Qualifications:
- Strong interpersonal skills
- Ability to analyze and optimize manufacturing and quality systems
- Product, design & prototyping
- Ability to create and provide training
- Software application skills
- Problem solving ability
- Ability to create, review and coordinate test protocols and reports
- Ability to generate engineering proposals
- Oral and written presentation skills
- Ability to lead cross functional teams
- Understanding of regulatory requirements
- Ability to create and/or update process mode failure effects analysis (pFMEA) and other related risk documents
- Education and/or Experience: At least 3-5 years of engineering or Quality engineering experience within the medical device or equivalent industry. Lean or Six Sigma Certified (Green or Black Belt) preferred.