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Baxter International Inc. · 1 day ago

Sr. Manager, Systems Engineering,

Round Lake, IL

Full-time

Hybrid

Senior Level, Lead/Staff

$144K/yr - $198K/yr

12+ years exp

Baxter International Inc. is dedicated to redefining healthcare delivery to make a greater impact. The Senior Systems Engineering Manager will lead technical teams in applying standard engineering principles to manage complex projects, ensuring alignment with organizational goals in medication delivery and infusion systems.

BiotechnologyClinical TrialsHealth CareMedical

No H1B

Responsibilities

Leads Infusion System Platform development and life cycle management activities

Drives Connectivity requirements development for electro-mechanical devices and software applications across portfolio of products and ensuring appropriate cyber security risks are mitigated

Functional management of Lead System Designers, Product Design Owners, System Engineering staff, System Engineering process, and Systems Engineering work products

Ensure compliance to the product development process and Quality System requirements

Manage external partnerships, contractors and 3rd party service providers

Guide, mentor, and provide direction to System Engineers

Collaborate with other system engineering teams within the organization to establish best practices

Develop strategic resource plans and budgets for global engineering resources/labs

Direct technical leaders on multiple programs who are responsible for the following:

Development of Design Requirements and Risk Management strategy

Translating user needs into system requirements, leveraging cross functional partners

Leading engineering resources (Electrical, Mechanical, and Software) in the decomposition of system requirements to derived requirements

Defining test strategies to allow the development of systems verification plans using requirement tracing methods

Leading risk analysis activities from the capture of inherent hazards through mitigation, including quantitative residual risk calculation in support of the Safety Assurance Case

Implementing configuration and change management through the complete product life-cycle, including design, development, and sustaining phases

Interfacing with Medical Affairs, Regulatory, Manufacturing, Service, Product Surveillance, Supply Chain, and Customer Training staff through the design transfer process

Qualification

Systems EngineeringRisk ManagementRequirements ManagementDesign Control RequirementsDFSSDMAICConfiguration ManagementLeadership EffectivenessCommunication SkillsCollaboration

Required

BS in relevant engineering disciplines, MS preferred

12 years of experience

Must be well versed in areas of System Engineering around complex therapy systems comprising electro-mechanical systems/sub-systems, as well as disposables

Requires strong organization and communication skills, with the ability to interface with both technical and non-technical personnel

Must be able to provide solutions that reflect understanding business objectives and cost implications

Experience with requirements management, design control requirements (CFR 820.30, ISO 13485), and risk management (ISO 14971)

Proven track record of management/leadership effectiveness

Preferred

Experience in application of DFSS, DMAIC and CMII techniques/principles are plusses

Benefits

Medical and dental coverage that start on day one

Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance

Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount

401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching

Flexible Spending Accounts

Educational assistance programs

Paid holidays

Paid time off ranging from 20 to 35 days based on length of service

Family and medical leaves of absence

Paid parental leave

Commuting benefits

Employee Discount Program

Employee Assistance Program (EAP)

Childcare benefits

Company

Baxter International Inc.

Glassdoor3.7

For nearly a century, we have delivered on our commitment to saving and sustaining the lives of patients, working alongside clinicians and providers around the world.

Founded in 1931

Deerfield, Illinois, USA

10001+ employees