Job Specifications
Job Title: Process Development Engineer
Location: Minneapolis, MN
Experience: 3+ Years
Employment Type: 12+ months Contract
Position Summary
We are seeking a skilled and detail-oriented Process Development Engineer with expertise in plastic injection molding, test method validation (TMV), and statistical analysis using Minitab. This role is critical in developing, validating, and optimizing manufacturing processes for medical devices while ensuring compliance with FDA, ISO 13485, and GMP standards.
Key Responsibilities
Lead and support plastic injection molding process development, optimization, and troubleshooting for medical device components.
Develop, execute, and report on Test Method Validation (TMV) activities including protocol creation, data analysis, and documentation.
Apply statistical tools in Minitab (DOE, SPC, GR&R, process capability studies) for process validation and continuous improvement.
Collaborate with cross-functional teams (R&D, Quality, Manufacturing, Supply Chain) to ensure efficient product development and transfer to production.
Support Design for Manufacturability (DFM) and actively contribute in product design reviews.
Create and execute IQ/OQ/PQ protocols for molding equipment, tooling, and processes.
Drive root cause analysis and implement corrective/preventive actions (CAPA) for deviations and nonconformances.
Ensure strict compliance with FDA regulations, ISO 13485, GMP, and internal quality system requirements.
Prepare technical reports, validation documentation, and records to support audits and regulatory submissions.
Partner with suppliers on tooling, material selection, and molding process improvements.
Qualifications
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Plastics Engineering, or a related discipline.
Minimum 3 years of experience in the medical device industry, specifically in plastics injection molding.
Strong background in Test Method Validation (TMV).
Proficient in Minitab and statistical analysis techniques.
In-depth understanding of GMP, FDA regulations, ISO 13485, and validation protocols.
Hands-on experience with IQ/OQ/PQ, DOE, SPC, and GR&R.
Excellent problem-solving abilities and effective cross-functional communication skills.
Preferred Qualifications
Experience in tooling design and mold qualification.
Knowledge of the medical device product development lifecycle (design controls).
Six Sigma Green Belt or higher certification.
About the Company
Established in 2014, Stark Pharma is a trusted consulting service partner for pharmaceutical, medical device, biotech, and IT clients. With direct operations in USA, Canada, and India, we bring a wealth of expertise and tailored solutions to help our clients achieve their strategic goals. Our Services: 1. Pharma, Medical Device & Biotech Consulting: We specialize in delivering expert guidance across: * Design & R&D * Formulation Development * Analytical R&D * Regulatory Affairs * Validation & Quality Assurance * Manufacturin...
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