IRP Medical is seeking a
Senior Manufacturing Engineer specializing in medical device components, with deep expertise in LSR and EPDM processing, automation, and scalable production in regulated cleanroom environments. Proven ability to lead process development, validation (IQ/OQ/PQ), and continuous improvement initiatives.
ESSENTIAL DUTIES AND RESPONSIBILITIES: - Lead the development, optimization, and validation of manufacturing processes for medical device components utilizing Liquid Silicone Rubber (LSR) and EPDM materials
- Drive automation initiatives, designing automated solutions to reduce manual labor and improve process consistency and throughput. Integration of robotic systems, vision systems, and automated assembly equipment.
- Partner with tooling and equipment vendors to design and procure molds, fixtures, and automation systems tailored to elastomer processing
- Design and implement robust, scalable manufacturing processes that meet stringent regulatory and quality requirements (e.g., FDA, ISO 13485)
- Support new product introduction (NPI) by ensuring designs are manufacturable, scalable, and compliant with medical device standards and risk management requirements
- Develop and execute process validation protocols (IQ/OQ/PQ), ensuring full traceability and compliance with regulatory expectations
- Create and maintain comprehensive documentation, including process flows, PFMEA, control plans, validation reports, and standard operating procedures (SOPs)
- Optimize LSR and EPDM molding processes (injection and compression), including material handling, mixing, curing, and post-processing, with a focus on consistency and biocompatibility
- Troubleshoot and resolve complex issues related to molding defects, contamination, tooling wear, and process variability in controlled environments
- Collaborate with Quality and Regulatory teams to support audits, CAPA investigations, nonconformance resolution, and change control processes
- Specify, source, and qualify molds, tooling, and automated equipment, ensuring compatibility with cleanroom and medical-grade production requirements
- Implement in-line inspection and validation technologies, including vision systems and automated testing for critical-to-quality (CTQ) features
- Support maintenance teams with preventive and predictive maintenance strategies for manufacturing equipment
- When requested, helps to train production operators and technicians in the manufacture of more complex parts and assemblies.
REQUIRED QUALIFICATIONS - Bachelor's Degree in Engineering or minimum 6 years of experience in a technical capacity in an injection molding environment
- Experience in liquid silicone rubber, EPDM and rubber molding in general
- Process Automation Experience
- Direct Experience with MRP
- Possessing Critical Interpersonal skills so as to Function effectively in a Team Environment
- Excellent oral and written communication
- Microsoft Office (Excel, PowerPoint, Project, and Word)
PREFERRED QUALIFICATIONS: - CAD Experience
- Lean Six Sigma experience
- Experience working with 3 axis robots
- Bilingual English/Spanish
PHYSICAL REQUIREMENTS: - Able to use all five senses, use of both hands
- Able to lift 20 lb. Box
- Capable of operating some production equipment and necessary office equipment
- The employee is required to be able to function in a work environment where the noise level is usually moderate.
Benefits:At IRP Medical, we recognize how important your career and benefits are to you and your family. We offer a full suite of benefits, including medical, dental, vision, short and long-term disability coverage, accident insurance, critical illness insurance, basic and supplemental life insurance, employee assistance plan, retirement savings and matching, and other developmental opportunities. We are committed to supporting the way you live and work.
(Actual placement within the salary range is dependent on multiple factors, including but not limited to skills, education, experience and location)
