Overview

We are seeking a highly motivated and experienced Senior MSAT (Manufacturing Science and Technology) Process Engineer to join our innovative team. In this pivotal role, you will lead technical support and process optimization efforts across manufacturing operations, ensuring the seamless integration of scientific principles with engineering practices. Your expertise will drive continuous improvement, uphold regulatory compliance, and support product development from concept through commercialization. This position offers an exciting opportunity to influence cutting-edge biotechnology and medical device manufacturing processes, fostering a collaborative environment where scientific rigor meets engineering excellence.

Responsibilities

• Lead process development, validation, and transfer activities for biotechnological and medical device products, ensuring adherence to GMP, GLP, ISO standards, and FDA regulations.
• Collaborate cross-functionally with research, engineering, manufacturing, quality assurance, and regulatory teams to optimize production workflows and troubleshoot technical issues.
• Design experiments and analyze data using statistical tools to improve process robustness, yield, and quality outcomes.
• Develop detailed project schedules to meet milestones for product launches, process improvements, and validation activities.
• Utilize CAD software such as SolidWorks and other 3D modeling tools for mechanical design and product development; incorporate GD&T principles for precise manufacturing specifications.
• Conduct laboratory experiments involving assays, cell culture, molecular biology techniques, and biomedical testing to support research and validation efforts.
• Ensure compliance with design controls, design of experiments (DOE), and engineering validation protocols while maintaining documentation aligned with regulatory standards.

Requirements

• Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, Biotechnology, or related field; PhD preferred for advanced research roles.
• Proven experience in project management including project scheduling and cross-functional collaboration within a regulated environment.
• Strong knowledge of biotechnology processes, including cell culture techniques, assays, molecular biology methods, and biomedical regulatory compliance.
• Proficiency in CAD software such as SolidWorks or similar 3D modeling tools; experience with GD&T standards is highly desirable.
• Familiarity with manufacturing practices including GMP/GLP/GMP environments; experience with medical device design and FDA regulations is a plus.
• Skilled in data analysis using statistical methods; experience with design of experiments (DOE) and experimental design is essential.
• Technical proficiency in engineering product development, mechanical design for medical devices, laboratory testing procedures, and validation protocols.
• Excellent communication skills to facilitate collaboration across multidisciplinary teams; ability to interpret complex technical data clearly.

Join us in shaping the future of biotechnology and medical device innovation by applying your expertise in process engineering! We are committed to fostering a dynamic environment where your skills can thrive while contributing to meaningful advancements in healthcare technology.

Pay: $110,000.00 - $123,000.00 per year

Work Location: In person