Principal Quality Engineer

Resonetics is a global leader in advanced engineering prototyping product development and micro manufacturing driving innovation in the medical device industry. With rapid expansion across all our locations we continue to push the boundaries of technology while fostering a dynamic employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger.

This Principal Quality Engineer applies advanced Quality Engineering and scientific method techniques and principles to daily tasks and activities; applies relevant regulations standards and industry best practices to assignments; plans and conducts projects and activities with high technical responsibility complexity and strategic input; Acts as a subject matter expert in all Quality Engineering and scientific matters; Develops and leads key strategic quality initiatives throughout the organization; receives periodic strategic guidance from QE Management or Director in addition to other senior functional leaders/stakeholders.

Join Resonetics and be part of a team thats redefining medical device manufacturing. If youre passionate about innovation and thrive in a fast-paced environment wed love to hear from you.

• Demonstrates high level of proficiency in applying established tools and methods to identify and realize new products or process introductions (ex. QMS product related) and business improvements.
• Leads the use of and/or develop innovative applications for risk management and risk mitigation tools and practices.
• Leads and/or contributes to root cause investigations of complex issues/problems using various problem-solving techniques and tools and assesses effectiveness of implemented corrective and preventive actions.
• Leads and/or contributes to the development of new detection systems by developing optimal methods for conducting equipment process and product qualifications/validations.
• Develops process Quality control plans that are in accordance with product utilization and risk level.
• Develops reviews implements and/or maintains production and process controls systems using appropriate techniques and tools (ex. Statistical process controls statistical inspection sampling).
• Ensures all levels of Design Controls per ISO 13485:2016 and QSR 21 CFR 820 are being utilized in addition to other product regulatory requirements.
• Leads or participates in design/technical reviews as appropriate.
• Leads QE on product development projects.
• Interprets and implements standard and non-standard sampling plans.
• Acts as a subject matter expert (SME) in all routine Quality areas (except for Quality Data Analysis related to company metrics)
• Partners with senior technical leaders (internal and external to the organization) to develop and implement innovative approaches for identifying technical opportunities and quality and business improvements.
• Mentors others in various technical capabilities.
• Partners with senior technical leaders to develop innovative approaches for achieving technical and business improvements.
• Collaborates with other quality leaders to identify required Quality Engineering skills and competencies.
• Serves as the second to acting Quality Manager or Quality Director.

• Strong Understanding of quality management systems and ERP systems.
• Strong project management experience leading cross-functional teams/tasks.
• Strong analytical and data-driven approach with proven problem-solving abilities.
• Strong presentation written and verbal skills.
• Ability to communicate with all levels within the organization.
• Solid team leadership team building and facilitation skills.
• Demonstrated mediation skills and ability to resolve apparently conflicting requirements through effective communication.
• Ability to facilitate a collaborative working environment for customers and team members.
• Ability and willingness to travel. Familiarity with FDA QSR ISO 13485 and ISO 14971 and other medical device related standards such as ISO 10993 ISO 11607 ASTM D4169.
• Experience in all phases of the medical device product development lifecycle.

• Minimum 5 years professional experience in medical subassembly and finished device manufacturing.
• Technical degree in Mechanical or Biomedical Engineering.
• Depth of knowledge in one or more clinical areas.
• Proficiency in Minitab or similar statistical analysis platform Knowledge of probability and statistics.
• Experience with transfer to production and/or sustained manufacturing of complex medical devices.
• Able to work in an office environment and travel independently.
• CQE and/or Six Sigma Green or Black belt.
• BS degree: Physics Optics Mechanical Chemical Plastics Engineering preferred.

• Standing and walking for short periods of time
• Ability to use a microscope including manipulating small objects under a microscope

The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $90000 - $140000.

Resonetics will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.