Device Engineer

Description

Length of Contract: 1 year, potentially renewing.

Location/Site: North Chicago: AP31 and/or R13

Remote, 100% Onsite, or Hybrid Onsite Schedule: Hybrid Onsite. 100% onsite will be required for stretches of work.

• Cross function collaboration with outside companies(small degree), Operations QA organization (high collaboration)
• Primary system level testing involving pump itself and infusion set and various infusion sets and various syringes, flow test stands looking at accuracy trumpet curve testing is most of testing
• IEC 60601-1 exp or other similar standards like on body infusion devices, diagnostics devices preferred
• 60% planning and developing protocols
• How can we set up design history file such that we can quickly quality additional infusion sets as more come online that we need
• preferably medical device that deliver drugs in body like infusion pump
• Responsible for life cycle management so we are in process of device revision and device development so there is additional potential testing associated with that
• Have included additional infusion sets, additional vile adaptors, confirmatory testing that the pumps ability t deliver under various conditions
• Team is supporting infusion pump
• Primary supporting design revision and Design refinements to an existing infusion pump
• Involved in characterization of functions that are not a part of specification of pump
• Exp with electromechanical devices
• Assisting in planning a verification strategy for larger initiatives like additional infusion sets
• Will be doing planning and protocol writing
• 20 -30% in lab actually conducting testing
• Infusion pump are class 2 medical device
• Additional test: tensile compression testers for forces to attach and detach components, torque to attach and detach components
• Bachelors Degree in Engineering or physics is needed

• Exp with verification of electromechanical devices (Must have)
• Proficiency in solid works or CREO (Develop test fixture)

What are the top 3-5 skills, experience or education required for this position:

• Design Verification of electromechanical devices
• Infusion pump or on body infuser development or sustaining engineering experience
• Authoring of test plans, protocols, and reports
• Good documentation practices
• Cross-functional collaboration

Job Description:

• The Senior Engineer position within the Science and Technology (S&T) organization is responsible for the development, improvement, and verification of electro-mechanical medical devices.
• This technical expert will, with little supervision, primarily apply engineering knowledge and ingenuity in the execution of design improvements.

Responsibilities:

• Manage device design changes by interfacing with cross-functional teams both at manufacturing partners and within client. Team member has full awareness of the potential consequences (defects and failure modes) of design changes to electromechanical drug delivery devices. Mitigates risk through strong technical acumen, detailed planning, and engineering confidence testing.
• Verification testing (planning, fixture development, test method validation, protocol development, and test execution).
• The team member will be responsible for multiple, often concurrent, projects including those involving external development partners.
• Propose device refinements based upon patient feedback, manufacturing records, and feedback from other stakeholders.
• Conduct analyses (e.g. calculations, tolerance analysis, etc.) as needed to improve product and component designs.
• Lead and/or participate in root cause investigations and design solutions for complex engineering problems.
• Responsible for compliance with applicable procedures, regulations, and standards (e.g. IEC 60601-1:2020, ISO 10993-1:2018).
• Ensures quality and effectiveness of projects through sound design, early risk assessments, and implementation of fallback strategies.
• Maintains device history file
• Some travel may be required

Qualifications:

• A Bachelors Degree in Engineering with a desired 8+ years of significant engineering experience.
• A post-graduate education / degree is desired and may contribute towards the desired years of experience.
• Has a career history marked by a consistent series of technical contributions and accomplishments.
• Interacts well with diverse groups within engineering and maintains strong working relationships with internal and external collaborators.
• Proficient in Solidworks