At Owens & Minor, we are a critical part of the healthcare process. As a Fortune 500 company with 350+ facilities across the US and 22,000 teammates in over 90 countries, we provide integrated technologies, products and services across the full continuum of care. Customers—and their patients—are at the heart of what we do.

Our mission is to empower our customers to advance healthcare, and our success starts with our teammates. 

Owens & Minor teammate benefits include:

• Medical, dental, and vision insurance, available on first working day

• 401(k), eligibility after one year of service

• Employee stock purchase plan

• Tuition reimbursement

• The anticipated salary range for this position is $90,300.00 - $167,700.00 USD Annual yr/annual. The actual compensation offered may vary based on job related factors such as experience, skills, education and location.

General Expectations and Accountabilities:

Development of the Risk Management files which includes Product Hazard list, Design FMEA, Use FMEA & Process FMEA.  Ensure that all elements of the corporate Human Resources Development and Diversity policy are fully supported as appropriate for the position.  Manage self and/or team in accordance with the expected behaviors of the Leadership Qualities.  Provides technical leadership in solving challenging technical problems related to quality issues and technologies.  Develops, initiates, and implements new quality concepts, tools and strategies to improve business practices.  Solves highly technical complex problems, provides expertise in related specific field of knowledge and consults on complex issues and projects.  Assists with the transfer of knowledge of technical skills and is viewed as a Subject Matter Expert.

Position Specific Accountabilities:

 Engineering and Leadership for the Global Medical Device Business Support Sustainability and New Product Development

• Actively participate in and/or facilitate the development of deliverables required for medical device change control and product development.
• Actively participate in product development plans, specifically components that focus on design reviews, quality plans, design transfer, and design verification/validation.
• Direct all activities necessary for the project team to achieve design control and change control deliverables, specifically deliverables related to product safety and performance.
• Ensure new and existing products meet customer requirements and specifications.
• Lead and ensure compliance to all risk management requirements.
• Partner within cross functional teams to determine root cause and mitigations of product issues as they arise during the product life cycle.
• Where appropriate, implement Design of Experiments and Problem Analysis/Solving concepts in conjunction with R&E.
• Actively participate in the development of statistical plans and rationale for change control and design control activities/requirements.
• Actively partner with the project teams to facilitate the incorporation of all quality system elements, root cause analysis, corrective action and continuous improvement principles throughout the entire product redesign.
• Support and facilitate updates to the Design History File.
• Where appropriate, incorporate the concepts of Lean Six Sigma to solve product/ process nonconformance issues.

• Systems Compliance 

• Ensure new product development and business support projects are in compliance with medical device regulations and internal procedures.
• Implement the Root Cause Analysis concepts to investigate issues requiring Corrective and Preventative Actions.
• Lead, participate in and/or facilitate in monthly complaint review meetings (as needed).
• Lead the GPMS Reviews reports data compilation and analysis.
• Active participation in risk analysis on incident escalations to management.
• Review, approve and be actively involved in the maintenance and updates to design history and risk management files.
• Participate in internal and external audits as needed.

• Maintain personal compliance to all internal systems as required, such as training, deliverables.

  Key Relationship / Customer Expectations:

• All levels of management within Operations Quality, Quality Systems, Research & Development, Medical Science,  Marketing, Legal, Market Research, External Consultants and Research Organizations, Vendors direct and through Sourcing and Supply Management, Finance, and Product Supply.

If you feel this opportunity could be the next step in your career, we encourage you to apply. This position will accept applications on an ongoing basis.

Owens & Minor is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, sex, sexual orientation, genetic information, religion, disability, age, status as a veteran, or any other status prohibited by applicable national, federal, state or local law.