Overview
On Site
Full Time
Skills
Continuous Improvement
Evaluation
Product Development
Documentation
Product QA
Regulatory Compliance
GMP
Process Engineering
Manufacturing
Quality Assurance
Medical Devices
IQ
OQ
PQ
Test Methods
Technical Writing
Design Of Experiments
Minitab
Microsoft Excel
DRM
Conflict Resolution
Problem Solving
Analytical Skill
Communication
Job Details
Job Description:
- The Process Development Engineer will lead the design, development, and validation of robust manufacturing processes to support new product development and continuous improvement initiatives.
- This role is critical in ensuring products are designed and manufactured with quality, reliability, and cost efficiency in compliance with industry regulations.
- Lead the exploration, evaluation, and integration of new process technologies into product development or existing manufacturing lines.
- Partner with cross-functional engineering teams to design and develop manufacturing processes that optimize yields, cost, and quality.
- Plan and execute manufacturing studies to characterize process inputs and define critical process specifications using Design of Experiments (DOE) and statistical methods.
- Identify, develop, and qualify required equipment, tooling, and fixtures for pilot and production operations.
- Generate and maintain documentation including engineering protocols/reports, PFMEAs, work instructions, and other regulatory-compliant records.
- Develop and execute equipment qualifications (IQ, OQ, PQ) and process validation activities.
- Lead test method development and validation to ensure robust product testing.
- Ensure compliance with Good Manufacturing Practices (GMP), internal quality procedures, and applicable regulations.
- Bachelor's degree in engineering (minimum); advanced degree preferred.
- 4+ years of experience in process development, manufacturing, or quality engineering within a regulated industry (medical device experience strongly preferred).
- Strong knowledge of process validation (IQ, OQ, PQ) and test method validation.
- Experience creating detailed work instructions and technical documentation.
- Solid understanding of statistical techniques and analysis; proficiency with DOE.
- Proficient in Minitab, Excel, Word, and MS Project.
- Experience with Design for Reliability and Manufacturability (DRM).
- Excellent problem-solving, analytical, and communication skills.
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.