Overview
On Site
Depends on Experience
Contract - W2
Skills
Systems Engineer
medical device
risk management
Medical Devices
Regulatory Compliance
Risk Assessment
Electro-Mechanical medical device
Job Details
Location: Onsite 5 days a week in North Chicago. Interviews will be held on-site. Please make sure your candidate is available to interview in person.
Duration: 12-month Contract
Notes:
- Location and schedule:
- 5 days per week onsite.
- Role:
- Senior Systems Engineer (5+ years minimum) in the medical device space.
- This is an Engineer role, not a heavy IT role. This person MUST have experience with the full medical device life cycle, having a core background in mechanical and/or electrical engineering.
- Entering a phase of product improvement prior to launch. Needs to put together change controls, scoping those requirements, risk management impact, verification tests, etc.
- Required:
- Must have experience with medical device testing.
- Medical Device development lifecycle.
- Must have 5+ years experience (
- Preferred:
- Bachelor's degree preferred, not required.
- Duration:
- 1 year contract minimum.
- Interview Process:
- Interviews held onsite. Likely 2 rounds of interviews.
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
Requirements: Bachelor of Science degree with 5+ years of experience in medical device development roles.
Desired: Graduate degree in a technical or scientific field. Prior experience with infusion systems (pumps and disposables) device development.
Environment: Electro-Mechanical medical device development office and laboratory settings.
Schedule: Eight hours a day, forty hours a week. Flexible schedule depending on the testing needs. There will be occasional overtime required, less than four hours a week.
On Site: Nearly all the work will be done on-site. There might be one day in two weeks that the candidate may be able to work from home to catch up documentation.
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
Requirements: Bachelor of Science degree with 5+ years of experience in medical device development roles.
Desired: Graduate degree in a technical or scientific field. Prior experience with infusion systems (pumps and disposables) device development.
Environment: Electro-Mechanical medical device development office and laboratory settings.
Schedule: Eight hours a day, forty hours a week. Flexible schedule depending on the testing needs. There will be occasional overtime required, less than four hours a week.
On Site: Nearly all the work will be done on-site. There might be one day in two weeks that the candidate may be able to work from home to catch up documentation.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.