Tijuana - Senior 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

What you will do in this role:

The primary purpose of this position is to 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.

Lead Life Sciences Activities

• You will be a subject matter expert in at least one Life Sciences area. 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 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 assist in determining 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 quality.
• Provide support of Integer’s Manufacturing Excellence and Market Focused Innovation Strategies
• Participation or leadership through Site Hoshin Plans, Quality Plans, Validation master plans, associated quality improvement imperatives
• Provide leadership as required for QA RA weekly and monthly metrics, supporting the walk to 5 sigma.
• Leadership of Sustained Change ensuring customer change notifications are initiated and completed, as necessary, and supporting continuous improvement activities as required.
• Support the standardization through workplace organization & visual controls (5S), Manufacturing Standard Work, and robust training & certification programs where applicable.
• Associate Engagement promoted through the adoption of standardized problem solving. methodologies, behavior-based safety programs, and improvement idea and suggestion systems.
• Systems & Process Optimization through adoption of principles of built in quality.

How you will be measured:

The specific measures listed below may be subject to change and are not intended to be an all-inclusive list.

• Safety is our highest priority; you will be an active supporter of the Integer Environmental, Health & Safety programs.
• You will have defined Goals and Objectives specifying key projects and expected milestones to achieve.
• Quality – Achievement of site Quality KPIs
• Innovation and ideation are critical aspects of your role and you will be expected to generate continuous improvement suggestions and support the implementation of them.

What sets you apart:

• You have earned, as a minimum, a bachelor’s degree in Biology, Microbiology, or related technical field and may have earned a Master’s or Doctorate Degree.
• You are technically seen as a very competent technical contributor, a recognition you have earned through 7+ years of progressive Life Science related and/or technically focused roles and experiences.
• If you do not meet the education requirements, you may be considered with 10+ years of relevant experience.
• You have experience in the medical device or pharmaceutical industry including US and international regulatory submissions/approvals.
• You have experience with patient contact devices including implantable devices and/or other high-risk device types. 
• You have knowledge of and experience with of sterilization validations and/ or biological evaluations and are suitability qualified as competent in sterilization and/ or biological evaluations.
• You have knowledge and experience with various medical device regulations such as the Medical Device Regulation (2017/745) and 21 CFR Part 820 and their application 
• You have a strong technical and problem solving foundation, with abilities to observe, analyze, and develop solutions to challenging technical issues resulting in the delivery of measurable results.
• You demonstrate a solid technical aptitude with the ability to be an effective contributor to the team or produce results of a technical nature as an individual.
• You will demonstrate the ability to lead team activities and act as a coach for other less experienced associates.
• You will have well-developed written and oral communication skills as clear and professional communication is important in this role.
• You maintain a calm demeanor that transcends the high energy, constantly changing product environment.
• You possess a positive, can-do attitude with an underlying belief that failure is not an option.

Working Conditions:

• The working environment varies from a standard office environment to laboratory and production areas including cleanrooms with varying physical conditions, gowning requirements and high noise levels.

U.S. Applicants: EOE/AA Disability/Veteran