Senior NPD Quality Engineer

Senior New Product Development (NPD) Quality Engineer

The Senior New Product Development (NPD) Quality Engineer provides Quality Engineering leadership on new product development projects in the areas of Design Controls and Design Transfer to Manufacturing including, but not limited to:
Risk Management, Design Verification and Validation Strategies, and Design Transfer to Manufacturing. This role is for our Mitek Sports Medicine organization supporting our soft tissue solution portfolio of products.

Duties & Responsibilities

• Independently provide directions and oversight of the new product development quality activities across assigned projects.
• Apply various tools and methods (for example, Six Sigma, Lean) to identify and realize new product or process introductions as well as process improvements.
• Apply various risk management and risk mitigation tools and practices, for example, mistake proofing, critical control points, failure mode and effects analysis.
• Supports the reliability assessments of product design.
• Lead root cause investigations using various problem-solving techniques and tools and assess effectiveness of corrective actions.
• Conducts, and supports the development of, test methods in equipment, process, and product qualifications/validations.
• Ensures that process Quality control plans are in accordance with product risk level and are consistently followed.
• Implements and/or maintains, production and process controls using appropriate techniques (for example, process capability measures, statistical process controls, and process performance metrics).
• Participate in technical reviews as appropriate.

Additional Duties

• Responsible for communicating business-related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

Experience and Education

• A minimum of a Bachelor's degree is required. Degrees in Engineering or related technical/scientific field is preferred.
• A minimum of 4 years of regulated industry experience in quality, new product development, or manufacturing engineering capacity is required.
• Strong knowledge of Quality Engineering/Scientific methods and techniques.
• Strong knowledge of GD&T and inspection methodologies.
• Experience with a proven track record of implementing appropriate risk mitigation.
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
• Experience handling tasks or small projects and demonstrating project leadership abilities.
• Strong communication skills and teamwork skills to support partnering cross functionally.

Required Knowledge, Skills, Abilities, Certifications/Licenses and Affiliations

• Ability to effectively collaborate and communicate with internal and external partners and demonstrate strong interpersonal, organizational, and verbal/written communications skills.
• Experience working in both an FDA and European regulatory environment is preferred.

Required Skills:

Preferred

Skills:

Agility Jumps, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Database Backup, Data Savvy, Disruptive Innovations, Issue Escalation, Problem Solving, Process Oriented, Product Improvements, Quality Control (QC), Quality Control Testing, Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing

The anticipated base pay range for this position is:

$92,000.00 - $

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's…