Sr Principal Engineer

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients- that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us is driven to help improve patients' lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Your role

This is where your expertise helps people

You are a problem solver. Sophisticated projects or unexpected challenges are just opportunities to bring your considerable abilities to use. Whether working independently or with a trusted team, you are always ready to tackle a project and work hard to find solutions.

Your talent is needed across a wide variety of industries. As a Quality Engineer Intern, you have a wide array of career choices, but are motivated by the opportunity to work in a company that supports innovation, professional development, and a purposeful mission.

Your team

We are a team of inquisitive individuals who embrace a collaborative environment to tackle sophisticated challenges that meet the needs of our patients. We often need to change directions and respond to issues to avoid disruptions in our fast-paced manufacturing environment. Together, we build and maintain a positive work environment.

Our Quality Engineering Team is dedicated to quality. Delivering life-saving products is about getting them right, and our technical expertise and experience working in a manufacturing environment empower us to meet that challenge.

When you join us, you will work with a team of committed individuals who trust each other to deliver on the tasks at hand. We support innovation and out-of-the-box thinking balanced with teamwork across functions and other teams. Our leadership understands the need for continuous education and provides opportunities for further development.

The Sr. Principal Engineer Supervises/coordinates Quality Engineers, Associate Engineers, Co-op Engineers and Quality personnel. Provides engineering support to Quality Management through statistical analysis, process optimization, factory acceptance, qualifications, defect prevention, and provide a technical interface between Quality Management and Manufacturing. Ensure compliance with GMP/QSRs and all applicable ISO and Country Standards

What you'll be doing

• Supervises the professional and technical skills needed to accomplish requirements and supervises obtainment of these skills through subordinate training/development.
• The job contributes engineering/technical expertise and supervisory support to the Quality Management function of the manufacturing facility.The Senior Principal Quality Engineer is responsible for assuring product/process compliance to specification, ensure compliance with GMP/QSRs and all applicable ISO and Country Standards.This is accomplished through qualifications and ongoing defect analysis of production processes.In carrying out these functions the Senior Principal Quality Engineer must utilize engineering, statistical, and numerical analysis techniques and supervisory skills.
• The Senior Principal Quality Engineer cooperates in developing the system specifications for new machines/processes, pertinent specifications, SOP's and CQP's.This requires interfacing with Mountain Home Q.M., Manufacturing, Engineering and Divisional Engineering, Q.A. and Management.
• The Senior Quality Engineer assists Manufacturing through studies of existing as well as new equipment, through the use of screening experiments, optimization protocols and consultation in statistical evaluation of processes.
• The Senior Principal Quality Engineer provides and supervises the technical support for the department for the following:
• Construction of prototype process test and measurement devices used in Quality Assurance.
• Evaluation and purchase of new test equipment for Quality Management.
• Appraisals for existing process measurement equipment to determine if its function could be improved with better technology.
• Evaluation of changes to production processes that affect product quality.Verification through experimentation of the quality level of new processes and changes to existing processes.
• Statistical assistance to Quality Management and Manufacturing.
• Examination of existing specifications and SOP's in the light of new production techniques to determine if changes are needed, then development of the changes.
• Evaluation of sampling plans with respect to current quality levels and test methods and the rationale for selection.
• Generation of new specifications and SOP's for new processes.
• Testing required in conjunction with protocols, in-process risk assessment, and situation appraisal.
• Composition of protocols, final reports, studies, experiments, and general information reports for use by management.
• New mold approvals and new component qualification.
• Validation (via qualification phases) of new equipment and changes to old equipment.
• Improvement in the efficiency and accuracy of Quality Management test methods.
• Evaluation and corrective action of short term and long term sources of defects.
• Support of all Quality improvement processes and programs as delineated by the Business and Quality Plan.
• Assure compliance of manufacturing and quality control operations with respect to CQP's, corporate specifications, SOP's, Good Manufacturing Practices/Quality System Regulations (FDA 21CFR 820), Corporate Quality Manual (CQM), ISO 13485-2003, Canadian Medical Device Requirements (CMDR), MDD 93/42/EEC and other applicable standards and regulations.
• Oversees the filing, control and retention of manufacturing and quality documents.
• Oversees the document change control activities and distribution of documents within the facility.
• Initiating action to prevent the occurrence of any nonconformities relating to product, process, and quality system.
• Identifying and recording any problems relating to the product, process and quality system.
• Initiating, recommending, or providing solutions through designated channels.
• Verifying the implementation of solutions.
• Controlling further processing, delivery, or installation of nonconforming product until the deficiency or unsatisfactory condition has been corrected.
• Drive Engagement in the team through modeling our Leader Behaviors:
• Communication - actively keep work group informed.Own the message and speak with one voice with site leadership
• Recognition - regularly acknowledge and celebrate the achievements, contributions and efforts from the team
• Feedback - provide positive coaching and development of team members and consistently manage performance and behavior issues with dignity and respect
• Enabling Success - ensure team members have what they need to be successful on a daily basis, and in their career aspirations
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position requires standing and walking for extended periods of time
• This is a safety-sensitive position for purposes of the Arkansas Medical Marijuana Amendment

What you'll bring

• BS in Engineering and 5-8 years of relevant experience.
• Aptitude for working with mechanical and electrical equipment
• Statistical analysis expertise
• Good interpersonal communication skills
• Self-motivation
• Technical writing expertise
• Training/experience with automated data processing techniques
• Computer expertise
• Training/experience with regulatory requirements regarding validation

We understand compensation is an important factor as you consider the next step in your career. At Vantive, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is 120,00 to 180,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

Advanced Molding and Extrusion techniques (Learning / Doing (1)), Automation, reliability & smart manufacturing (Applying / Overseeing (2)), Critical Systems (Learning / Doing (1)), Data Analysis & Analytics (Applying / Overseeing (2)), Digitalization & Systems Engineering (Applying / Overseeing (2)), First Principles Thinking (Applying / Overseeing (2)), Lean & six sigma process knowledge (Applying / Overseeing (2)), Machine Learning & Artificial Intelligence (Not Applicable (0)), Manufacturing & Process Knowledge (Applying / Overseeing (2)), Modeling & Simulation (Leading / Driving (4)), Operational Quality Assurance (Applying / Overseeing (2)), Process Automation (Applying / Overseeing (2)), Product / Project Management (Applying / Overseeing (2)), Smart Operations / Industry 4.0 (Learning / Doing (1)), Software Integration (API, Data Pipelines) (Not Applicable (0))

US Benefits at Vantive

This is where your well-being matters. Vantive offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical, dental and vision coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Aon Pooled Employer Plan ("Aon PEP"), Vantive's 401(k) retirement savings plan, to help you prepare for your future. The Aon PEP is designed to help improve retirement outcomes by providing retirement resources more efficiently. The plan offers a robust set of investment options, financial education, and a suite of resources to support your retirement goals.

We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees.For additional information regarding Vantive's US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Vantive

Equal Employment Opportunity

Vantive is an equal opportunity employer. Vantive evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Know Your Rights: Workplace Discrimination is Illegal

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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