Senior Principal Systems Engineer, PDO

3 weeks ago

Plymouth, United States Baxter Full time

Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. 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 are driven to help improve patients' lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

Job Title: Sr Principal Systems Engineer, PDO

Your Role

As a Senior Principal Systems Engineer in the Product Design Owner (PDO) role, you will be responsible for supporting releases and updates to our existing Acute (CRRT) Therapy products. Based on both your technical and program management skills, you will implement sustaining and expansion activities into our commercially available product. This role will require you to review and approve design concepts/ changes and provide general direction to technical staff, including ensuring that quality is built into the design during development and subsequent implementation. This position is cross-functional in nature, so you will be collaborating directly with hardware, software, compliance, and operations. Proactively supervising the program and developing strategies to mitigate technical risks is expected as well as reporting on the progress to senior management during routine cadence meetings.

Essential Duties and Responsibilities

  • Key member of both the Systems Engineering team and Platform Engineering group
  • Perform activities associated with the Systems Engineering of one or more products in different stages of the product release cycle from development to post-market surveillance
  • Capture inputs for Requirements from various sources such as Standards, Usability, Regulatory, Quality, Human factors, Manufacturing, Service, etc.
  • Use knowledge of technology, process, and/or therapy domains to drive solutions and product design realization from a Systems perspective
  • Understand clinical and user needs to ensure safety and efficacy of product releases
  • Contribute to technical and design feasibility analysis of complex design concepts within area of expertise and then advise management regarding appropriate action
  • Independently plan and implement a series of design and/or technical tasks that may not be well-defined, have multiple variables, and require advanced execution strategies
  • Play a lead role in the evaluation, selection, and adaptation of various techniques to accomplish business objectives (e.g. quality, cost, and cycle-time)
  • Routinely provide advice and assistance to team members regarding unique problems
  • Devise innovative approaches to sophisticated problems through adaptation and modification of standard technical and design principles, then incorporate these new methods as appropriate
  • Build and maintain Design History File elements and ensure traceability to requirements
  • Influence partners and multi-functional team members within the project
  • Facilitate an improved understanding of the interrelationship between Requirements, Risk and Reliability
  • Anticipate technical challenges and risk scenarios and then prepare, lead, and execute mitigation strategies to ensure safe and effective results
  • Perform impact assessments on the Requirements on an ongoing basis for any proposed design/material/process change or an observation in the field/service or manufacturing to determine the impact and need for any mitigations, then propose recommended mitigations with the rationale
  • Drive consistency to FDA, ISO and IEC design control procedures, regulations, and standards
  • Use various software tools and programs (e.g. DOORS) to complete the above responsibilities
  • Maintain current knowledge of relevant Quality Management System (QMS) regulations and other regulatory requirements related to research and development (product development, design and safety) to ensure compliance in all research, data collection and reporting activities
  • Execute engineering change control efforts per established processes and manage the deliverables per QMS requirements
  • Coordinate design change implementation in production and into markets
  • Write and coordinate the design and development of system level requirements to meet service, marketing, engineering, commercial, regulatory, and compliance needs
  • Teach and mentor others in life cycle management methodologies

Qualifications, Education and/or Experience

  • A Bachelor's degree in Electrical, Mechanical, Biomedical, Controls, Systems, Software or other related technical/engineering field
  • 10+ years of industry work experience with minimum of 5 years in the medical device industry
  • Must possess sound knowledge of systems engineering and related areas such as electro-mechanical and software engineering as well as relevant standards (e.g. ISO 13485, IEC 60601, MDR)
  • A demonstrated track record in electromechanical system development, preferably medical devices or other highly regulated products such as military hardware
  • Experience using Product Development and Lifecycle Management (PDLM) tools and processes
  • Demonstrated strong analytical and problem-solving skills
  • Success in working with multi-functional, global teams
  • Excellent interpersonal/communication/influencing skills

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter 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.

EEO is the Law
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Pay Transparency Policy

Reasonable Accommodations

Baxter 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 here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our .

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