Highlights
The engineer will collaborate with cross-functional teams and external vendors to implement changes, resolve development challenges, and improve processes supporting marketed products. The Engineer III will support on-market medical device products through product lifecycle management, DHF, supplier change execution, and manufacturing support.
Numbers & Facts
| Location | North Lake County, IL |
| Industry | Staffing/Employment Agencies |
| Salary | $58–$62 Per Hour |
| Company Size | 500 to 999 employees |
| Website | https://www.thefountaingroup.com/ |
Description
Quality Engineer - DHF
Location: North Lake County, IL (Primarily onsite, with limited remote flexibility)
Pay: $58-$62/hr
Duration: 1 year with potential to extend/convert based on performance and budget
Schedule: Monday–Friday, 40 hours per week
Job Description
The Engineer III will support on-market medical device products through product lifecycle management, DHF, supplier change execution, and manufacturing support. This role will focus on maintaining product design documentation, ensuring regulatory compliance, and supporting product changes throughout the product lifecycle. The engineer will collaborate with cross-functional teams and external vendors to implement changes, resolve development challenges, and improve processes supporting marketed products.
Responsibilities
Preferred Qualifications
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy
Location: North Lake County, IL (Primarily onsite, with limited remote flexibility)
Pay: $58-$62/hr
Duration: 1 year with potential to extend/convert based on performance and budget
Schedule: Monday–Friday, 40 hours per week
Job Description
The Engineer III will support on-market medical device products through product lifecycle management, DHF, supplier change execution, and manufacturing support. This role will focus on maintaining product design documentation, ensuring regulatory compliance, and supporting product changes throughout the product lifecycle. The engineer will collaborate with cross-functional teams and external vendors to implement changes, resolve development challenges, and improve processes supporting marketed products.
Responsibilities
- Execute on-market product changes and support product lifecycle management activities.
- Maintain and manage Design History Files (DHF) and ensure appropriate documentation and traceability.
- Support supplier changes and product design updates for marketed medical devices.
- Review and execute testing activities, manage deviations, analyze data, and prepare technical reports.
- Ensure compliance with applicable global regulatory requirements and industry standards.
- Provide manufacturing and product design support throughout the product lifecycle.
- Collaborate with cross-functional teams and external vendors to communicate technical challenges and implementation strategies.
- Standardize and simplify team processes to improve efficiency in product development and ongoing product support.
- Bachelor's degree in Bioengineering, Chemical Engineering, Mechanical Engineering, or a related technical field.
- 3+ years of experience in medical device or pharmaceutical development.
- Experience with Design History Files (DHF), product lifecycle management, and documentation traceability.
- Experience executing on-market supplier changes.
- Knowledge of applicable regulatory requirements and industry standards, including MDR, ISO 13485, ISO 14971, and ISO 10993.
- Proficiency in test execution, deviation management, data review, and technical report writing.
Preferred Qualifications
- Graduate degree in a technical or scientific field.
- Experience with combination medical device or pharmaceutical product development.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy
About Company
The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.