Senior Manufacturing Engineering

Senior Manufacturing Engineer

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.

IRP Medical is a trusted leader in engineered elastomer solutions serving Medical Device, and aerospace markets. Our team designs and manufactures precision-molded seals, gaskets, and custom rubber components that perform in the most demanding environments. We take pride in craftsmanship, collaboration, and a culture built on innovation and reliability.

Lead the development, optimization, and validation of manufacturing processes for medical device components utilizing Liquid Silicone Rubber (LSR) and EPDM materials

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., 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

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.

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

Microsoft Office (Excel, PowerPoint, Project, and Word)

CAD Experience

Lean Six Sigma experience

Bilingual English/Spanish

Capable of operating some production equipment and necessary office equipment

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. IRP Medical is an Equal Opportunity Employer. We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected status. Applicants requiring reasonable accommodation to complete the application process may contact Human Resources.

This position requires access to information subject to the International Traffic in Arms Regulations (ITAR). S. citizens, lawful permanent residents, refugees, or asylees, as required by U.