Principal Life Sciences Specialist

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.

At Integer, our values are embedded in everything we do.

Customer

We focus on our customers’ success

Innovation

We create better solutions

Collaboration

We create success together

Inclusion

We always interact with others respectfully

Candor

We are open and honest with one another

Integrity

We do the right things and do things right

Who we are:

Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEM’s to enhance the lives of patients worldwide and high-end niche batteries for specialized applications in the energy, military, and environmental markets. We are guided by our six Values, including focus on Customers, Innovation, Collaboration, Inclusion, Candor, and Integrity. Working at Integer means you are part of a team passionately pursuing excellence in all that we do and always reaching for the next great achievement.

What you will do in this role:

The primary purpose of this position is to provide strategic Life Sciences guidance and leadership to others across Integer.  You will apply intensive and diversified Life Sciences knowledge in one or more of the following areas: sterilization, environmental monitoring, product cleanliness, and biocompatibility. This position is also responsible for mentoring junior associates in any or all of the Life Sciences areas and for compliance with all relevant external and internal Life Science requirements.

• Adheres to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.

Drive Life Sciences Strategy and Lead Life Science Activities

• You are recognized as a Life Sciences subject matter expert within Integer and are challenged to solve unique and complex problems that have a broad impact on the business. As a result, you may be directed to deploy your expertise across multiple organizations and/or locations and therefore, occasional travel may be required in this position.
• You will contribute to driving the Global Life Science strategy.
• You will lead continuous improvement projects.
• You will serve as a coach and mentor for other Life Science Specialists, modeling the behaviors and disciplines of a Life Sciences technical leader. 
• You will support regulatory and customer inspections, audits, investigations, and inquiries in the following areas: sterilization, environmental monitoring, product cleanliness, and biocompatibility.  
• You will review and apply the applicable standards and procedures, to provide support in one or more of the following areas: sterilization, environmental monitoring, product cleanliness, and biocompatibility.  You will also determine which standards and requirements are applicable to Integer in any or all of the Life Sciences areas.
• You will originate new documents such as protocols, reports, specifications, and work instructions; and you will also review documentation work products of your peers and others.
• You will perform work on technical projects, where you will follow Integer’s standard quality management, production system and/ or laboratory methodologies, to evaluate, maintain and improve the quality of medical devices.
• You will apply standard data analysis practices and techniques to establish root cause for out of specification results and to support the justification for improvements.
• You will lead cross-functional teams or technical projects and will have the skills to influence others to achieve goals.
• You will initiate and maintain relationships with individuals and business units within your site and organization.

Support Quality and Manufacturing Excellence Imperatives

• You embed Quality within all that you do – “I own Quality.”  You are a standard bearer for Quality in everything we do at Integer, by assuring adherence to our Quality Management System (QMS), facilitating and/or contributing to corrective and preventive actions, and contributing to the successful attainment of our quality KPI’s and journey differentiated qual