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Systems Engineer


Requisition Number: P11682

Region: US
State: Wisconsin
City: Hudson

Responsibilities

We are seeking an experienced Systems Engineer with expertise in development of medical devices, in particular, injectables and infusion pumps, to work at our Design Development Center in Hudson, WI (close proximity to Minneapolis/St. Paul, MN).

Provide technical guidance to a cross functional development team by utilizing tools in the Design Development Process (DDP), Quality Management System (QMS) and information in other relevant standards to identify product requirements and develop appropriate test plans to challenge the product; work closely with the test and quality group to trace product needs, design input requirements and design outputs.

• Work within the DDP and with a cross functional team to create appropriate product requirements for the product to be designed and developed to:
  -Learn and understand the Design Development Process and tools and the interdependencies of the different functional areas.
  -Research and learn appropriate ISO and other regulatory standards for applicable product types
  -Utilize system architecture diagrams, state transition diagrams and other tools to illustrate the appropriate sub-systems within the product and their relationship to one another.
  -Define the inputs and outputs needed to make the sub-systems work independently and then the system level inputs and outputs needed to make the system work when fully integrated.
  -Understand how to translate and articulate a user or stakeholder need into an engineering requirement.
  -Identify and assess Design Risk via a dFMEA
• Work with the development team identify risks and generate appropriate test plans
  -Generate a comprehensive test plan that characterizes the sub-systems and system.
  -Work with the test engineering group to ensure the test methods test the appropriate items and ranges.
  -Work with the design and manufacturing group to create appropriate design variants understand the impact of feature / size variation and performance.
• Improve existing designs provided by our customers or production sites:
  -Lead and/or co-facilitate a team through root cause analysis efforts.
  -Review customer supplied technical information and organize it into a meaningful structure.
  -Facilitate requirement identification brainstorming sessions utilizing tools such as FAST or other techniques.
  -Identify potential technical risks and potential solutions within the product design, utilizing proper decision making tools and data to drive decisions.
  -Participate in collaborative brainstorming (JumpStart®) sessions.
• Support program or project management by:
  -Assist with the creation of scope, cost and duration estimates for various tasks
  -Track and report time for various tasks, in a timely manner
  -Support program/project management and customer needs by being accountable for meeting project timelines and ensuring activities are supported by the project budgets.
• Support product compliance by working with the Quality organization:
  -Adhere to facility and corporate quality systems, SOP’s & WI’s
  -Know and understand personal role in compliance to ISO 13485 w/ design controls, ISO14971 risk management, IEC 62366, IEC 60601 and ITAR as required
  -Ensure that design inputs and outputs are properly documented and controlled according to relevant procedures.
  -Provide guidance to team members on project applicable product standards.
  -Work with Design Assurance to ensure Needs, Design Inputs and Design Outputs are all traceable.
  -Generate and control requirement documentation according to relevant work instructions.
• Facilitate communication between team members, customer and flow through production facilities
  -Travel to Customer and other Phillips-Medisize facilities as required to support business needs (mostly day travel).
• Some programs may have vision requirements
• Other duties as assigned

Qualifications - Education & Experience

• Bachelor of Science in Mechanical, Electrical or Systems Engineering with a minimum of 10-15 years of product development experience with a focus on system integration of drug / biologic delivery devices (pen injectors, auto-injectors and wearable pumps).
• Experience in medical device, combination products or disposable diagnostics, preferred.
• Educated in the integration of electronics and mechanical systems.
• Diverse product portfolio the use of applicable standards.

Qualifications - Skills & Competencies

• Competent in ISO 13485 Design Controls, ISO 14971 and IEC 62366.
• Proficient in the use of prioritization and decision making tools / techniques.
• Strong analytical ability to guide complex design teams
• Leadership skills including ability to lead, mentor and maintain confidentiality
• Competent in test protocol development and design verification activities
• Strong organizational, written, verbal and interpersonal communication skills
• English, other languages a plus
• Fluent in Microsoft Office programs including Visio, Excel, Word and Power Point.

This facility operates under International Traffic in Arms Regulations (ITAR), and therefore, any person hired must demonstrate with verifiable documentation that he/she is either: (i) a U.S. Citizen; (ii) an active Green Card Holder; or (iii) a “Protected Person” as defined by 8 U.S.C. 1324(b)(a)(3)

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