Manufacturing Engineer
Job Summary
We are seeking a highly skilled Manufacturing Engineer to join our team. The successful candidate will play a pivotal role in scaling up manufacturing processes from development to commercial production, focusing on new equipment introduction, process optimization, and validation.
Key Responsibilities
* Lead the selection, procurement, installation, and commissioning of new manufacturing equipment & utilities to support scale-up and commercialization efforts.
* Collaborate with suppliers to evaluate and qualify new equipment, ensuring compliance with design specifications and regulatory standards.
* Train team members on the operation and maintenance of newly introduced equipment.
* Support manufacturing onsite and at subcontractors/suppliers to ensure that the product quality, regulatory & business requirements are met.
* Track and report progress across project activities by reviewing schedules and due dates, identifying risks and implementing contingency plans. Communicate effectively with all internal & external stakeholders.
* Lead the transition/design transfer of manufacturing processes from R&D to production, ensuring scalability and cost-effectiveness.
* Lead the development and execution of pFMEAs to identify potential failure modes, assess risks, and implement effective controls for manufacturing processes.
* Optimize manufacturing workflows and identify opportunities for efficiency improvements.
* Support timely introduction of any new process upgrades by developing and executing equipment qualification protocols (IQ/OQ/PQ), integrating them into the overall process validation framework.
* Act as a subject matter expert (SME) in manufacturing technologies, troubleshooting complex process issues, and implementing robust solutions.
* Assess and approve process changes ensuring product impact is appropriately considered. Compile any necessary equipment/capital authorization requests supported with appropriate justifications and alternative options.
* Collaborate with key suppliers and their production/manufacturing teams to drive and support process/product improvements/developments.
* Ensure all health, safety and environmental requirements are met.
* Ensure compliance with medical device regulatory requirements, including FDA and ISO 13485 standards.
* Provide guidance and mentorship to junior engineers and technicians, fostering a culture of continuous learning and professional growth.
* Perform other related duties as assigned by their supervisor.
Requirements
* Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related field.
* A minimum of 3-5 years of experience in manufacturing engineering, preferably in the medical device or pharmaceutical industries.
* Strong expertise in process validation and equipment qualification in regulated industries.
* Qualifications and education with specialized knowledge of manufacturing with powders, particle processing, and granulation techniques, including safety, quality control, and process optimization, is highly advantageous.
* Knowledge and interpretation of FDA guidelines and ISO 13485 requirements with working knowledge of international standards as applicable.
* Proficient in lean manufacturing, Six Sigma, and other process improvement methodologies.
* Ability to manage multiple projects and prioritize workload effectively to meet project deadlines.
* Excellent communication, interpersonal and presentation skills.
* Strong technical acumen and ability to understand complex technical concepts/issues and develop practical solutions.
* Strong attention to detail and ability to work meticulously to ensure accuracy in testing and documentation.