Position                            : Test Validation Engineer

Location                          : Mannford, OK

Duration                          : 10 Months

Total Hours/week           : 40.00

1st Shift

Client: Medical Device Company

Job Category: Engineering

Level of Experience: Mid-Level

Employment Type: Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)

Hours M-F 8-5 with 1 hour lunch or long as total hours are 40 per week maximum. 8 hours a day 5 days a week.

Note: Will consider someone who is willing to relocate at their own expense. Please note on resume location if so.

Must haves:

Previous create/execute test method validations, technical writing skills, flexible work week to support timing of validation time availability in a manufacturing environment.

• BS in Engineering

• Three to five years’ experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry.

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 Senior Quality Engineer - Validation

• 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.

Project Management:

• Assists with 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.

Design to Manufacturing Transfer:

• Supports product and system updates in line with EU-MDR requirements while maintaining design intent and smooth transfer to manufacturing as it applies.

Test Method Development & Test Method Validation:

• Leads and creates the development and validation of clinically relevant test methods that adequately challenge product design and related processes.

Testing:

• Leads and creates verification and validation activities for products and processes in support of EU-MDR requirements.
• Other Responsibilities may include, however are not limited to:
• Support/lead design and process root cause analysis and support non-conforming product and complaint investigations.
• Ability to make and present risked 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.
• Assess product changes against product design when applicable.
• Supports translation of design inputs into manufacturing control plans
• Prepare and present project updates and technical discussions
• Provide support to the regulatory department in writing technical submissions
• Complies with company procedures and policies, government regulations
• Other duties and projects, as assigned.

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.
•  
• Physical Demands:

• The employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment.
• They frequently verbally communicate with other associates, and may reach with hands and arms and stoop, kneel or crouch.
•  
• Work Environment:
• While performing the duties of this job, the employee may be in an open cubicle environment.
• Candidate must be able to work in a team-oriented, fast-paced environment.
• Client is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.