Senior R&D Engineer - MediTech (Mitsubishi Chemical Advanced Materials)

Mitsubishi Chemical Advanced Materials•Wayne, NJ

12d•Hybrid

About The Position

Mitsubishi Chemical Advanced Materials is seeking a Senior R&D Engineer to join our MediTECH Division. This role focuses on developing the next generation of orthopedic implant materials and manufacturing technologies. It is a highly technical, customer-facing leadership position that integrates research, product development, project management, and process engineering. The engineer will lead new product and process development from concept to commercialization, collaborating with customers, suppliers, and cross-functional teams to bring innovative medical device solutions to market.

Requirements

Bachelor's degree in Engineering or a related technical discipline
5+ years of experience in the orthopedic or medical device industry
Experience leading product development and engineering projects from concept through commercialization
Strong understanding of engineering principles related to product design, materials, and manufacturing processes
Experience reading and interpreting customer specifications and engineering drawings
Demonstrated project management experience with the ability to manage multiple priorities simultaneously
Strong analytical skills with experience using engineering and statistical analysis software, including Minitab
Excellent technical writing, presentation, and communication skills
Ability to collaborate effectively with customers, suppliers, and cross-functional teams
Self-motivated with strong leadership and organizational skills
Proficiency with Microsoft Office and collaboration tools such as Microsoft Teams

Nice To Haves

Experience with medical device design controls (21 CFR 820.30)
Knowledge of FDA Quality System Regulations and ISO 13485
Experience with ISO 10993 biocompatibility standards
Knowledge of ISO 14971 risk management processes
Experience with Design History Files (DHF) and medical device documentation
Experience with implantable device materials, including metals, polymers, and surface treatments
Experience creating FDA Master Files
Background in orthopedic implant materials or surgical applications

Responsibilities

Lead New Product & Process Development: Lead research and development projects from concept through commercialization, develop innovative implantable material solutions for orthopedic surgical applications, design, execute, and document product and process development trials using laboratory and production equipment, and evaluate new technologies, manufacturing methods, and materials that support business growth.
Drive Technical Innovation: Lead technical evaluations, implementation activities, and process validations for new products, develop manufacturing methods, equipment specifications, and statements of work for production and development programs, and analyze complex materials and manufacturing challenges using engineering principles and data analytics.
Lead Cross-Functional Projects: Serve as project manager for capital projects related to product development, partner with Manufacturing, Quality, Design Engineering, and CAE teams to optimize product designs and manufacturing processes, and provide engineering support during production scale-up, troubleshooting, and process improvements.
Partner with Customers & Industry Leaders: Serve as the technical liaison for customers, suppliers, and external partners, lead customer, supplier, and vendor interactions related to product development and validation, and represent MediTECH through ASTM, ORS, Biomaterials organizations, and other professional societies.
Ensure Quality & Regulatory Excellence: Support product development activities in accordance with FDA Quality System Regulations and applicable ISO standards, prepare technical reports, validation documentation, and engineering records, and maintain confidentiality while ensuring compliance with quality, regulatory, and customer requirements.