Title:Development Process Engineer
Location:Plymouth, MN(100% Onsite)
Duration: 3+months
Pay Range: $30/hr to $33/hr (On W2)
Shift Time:08:00am to 04:00pm
We are looking for a ?Development Process Engineer? to join one of our Fortune 500 clients.
Job Summary:
Seeking a Process Development Engineer to join our dynamic team at our Plymouth, MN facility. This role is ideal for an engineer who thrives in a hands-on, fast-paced environment and is passionate about driving innovation, improving manufacturing processes, and ensuring product quality in a regulated industry.
As a Process Development Engineer I, you will play a critical role in the development, optimization, and validation of manufacturing processes. Your work will directly impact product quality, operational efficiency, and regulatory compliance.
Job Responsibilities:
\t- Process Development & Implementation: \t
- Lead the design, development, and implementation of new manufacturing processes and equipment. \t
- Specify, acquire, and validate new equipment to support production and process improvements. \t
- Problem Solving & Root Cause Analysis: \t
- Apply structured problem-solving methodologies to identify root causes of process issues. \t
- Develop and implement corrective and preventive actions (CAPAs). \t
- Data-Driven Improvements: \t
- Design and execute experiments (DOE), analyze data, and present findings to cross-functional teams. \t
- Drive continuous improvement initiatives to enhance product quality, reduce waste, and increase efficiency. \t
- Documentation & Compliance: \t
- Create and maintain technical documentation including SOPs, risk assessments, validation protocols, and safety instructions. \t
- Ensure all processes comply with internal quality systems and external regulatory requirements. \t
- Cross-Functional Collaboration: \t
- Work closely with R&D, Quality, Manufacturing, and Supply Chain teams to support product development and scale-up. \t
- Provide technical training and mentorship to technicians and junior engineers. \t
- Innovation & Technical Leadership: \t
- Evaluate and recommend new materials, tools, and technologies to improve manufacturing capabilities. \t
- Support tooling development and process validation for new and existing products.
Education:
\t- Bachelor?s degree in engineering (Mechanical, Biomedical, Chemical, or related field) with0-2+ yearsof relevant experience. \t
- Strong analytical and problem-solving skills. \t
- Proficiency in technical writing and documentation. \t
- Ability to work independently and collaboratively in cross-functional teams. \t
- Excellent communication and presentation skills. \t
- Working knowledge of manufacturing systems, automation, and process control.
Preferred Qualifications:
\t- Experience in themedical device industry, particularly withcatheter manufacturingor similar regulated environments. \t
- Familiarity withGMP,ISO 13485, andFDA regulations. \t
- Hands-on experience withprocess validation,DOE, andstatistical analysis.
We are looking for the candidate who are eligible to work with any employers without sponsorship.
If you?re interested, please click ?Apply? button
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