Job title: Product Development Engineer
Location: Minnetonka, MN
Duration:ย 12 Months
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Job Summary
The Product Development Engineer supports new product development and commercialization by executing engineering tasks, testing, documentation, data analysis, equipment qualification, and design control activities in a regulated medical/pharmaceutical environment.
Key Responsibilities
- Support new product development using engineering fundamentals.
- Install, qualify, and support R&D equipment.
- Perform engineering testing, data analysis, and technical report writing.
- Develop and validate test methods for materials and inspections.
- Maintain Design History Files (DHF) and support DFMEA/risk management.
- Prepare DMR documentation such as specifications, test methods, and manufacturing instructions.
- Participate in design reviews, root cause analysis, and failure investigations.
- Support technology transfer and process validation for new product launch.
- Ensure compliance with FDA regulations, and safety procedures.
Required Skills
- BS in Engineering; Mechanical or Biomedical preferred.
- Good understanding of design control and quality systems.
- Knowledge of statistics: Gage R&R, capability analysis, DoE, normality, acceptance sampling.
- Experience with technical writing and data analysis.
- Familiarity with FDA-regulated environments: 21 CFR 211, 21 CFR 820, ISO 13485.
- Knowledge of root cause analysis tools like 5 Whys and Ishikawa.
- Proficiency in Excel/Minitab.
For more information, please reach out at 732-719-4936 or share your updated resume with padma.priya@intellectt.com.