Sr Process Engineer
Sr Process Engineer
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1 Vacancy
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.
- Bachelors 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.
Employment Type
Full-time
