Test Validation Engineer

Job Description

We believe that the human element, across our global teams, is what allows us to continually evolve.

Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

Essential / Key Job Responsibilities

• EU-MDR support of submission documents; supports Quality activities surrounding EU-MDR submission of products through execution of identified remediation.
• Works with multi-functional teams to remediate gaps related to EU-MDR requirements and meets all deliverables in line with division and business goals.
• Affords assistance in creating strategic plans for EU-MDR elements of remediation.
• Coordinates with team members, internal and external peers, and outside professionals to ensure project output meet business needs as well as applicable regulatory requirements.
• Supports product and system updates in line with EU-MDR requirements while maintaining design intent and smooth transfer to manufacturing as it applies.
• Leads and creates the development and validation of clinically relevant test methods that adequately challenge product design and related processes.
• Leads and creates verification and validation activities for products and processes in support of EU-MDR requirements.
• Supports/leads design and process root cause analysis and support non-conforming product and complaint investigations.
• Makes and presents risk-based decisions.
• Technical leadership skills including an understanding of medical device operations (e.g., medical device manufacturing, process development, quality assurance).
• Leads and creates development of risk assessments and test methods.
• Leads and creates component qualifications, design validation / verification and process validation as applicable.
• Leads and creates product investigations.
• Assesses product changes against product design when applicable.
• Supports translation of design inputs into manufacturing control plans.
• Prepares and presents project updates and technical discussions.
• Provides support to the regulatory department in writing technical submissions.
• Complies with company procedures and policies, government regulations.

Required Qualifications

• Knows how products are used and impact the user(s) so that risk can be managed effectively.
• Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.).
• Ability to lead creation of risk management files (e.g. PFMEA).
• Ability to develop solutions with business impact.
• Advanced statistical and risk assessment techniques.
• Working knowledge and creating abilities for test method (development and validation), equipment qualifications, and validations, process and design validation, risk assessment techniques, and component qualification methodologies.
• 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, review and coordinate test protocols and reports.
• Problem solving ability.
• Ability to generate engineering proposals.
• Oral and written presentation skills.
• Ability to Lead cross functional teams.
• Understanding of regulatory requirements including ISO 13485, ISO 14971.

Preferred Qualifications

• Quality Engineering Certification (ASQ) or equivalent.
• Education and/or Experience:
• BS in Engineering
• Three to five years’ experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry.