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

What You'll Do

• Lead New Product & Process Development
• Develop innovative implantable material solutions for orthopedic surgical applications
• Design, execute, and document product and process development trials using laboratory and production equipment
• Evaluate new technologies, manufacturing methods, and materials that support business growth
• Prepare process, manufacturing, cost, and economic models to support new product initiatives
• 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
• Analyze complex materials and manufacturing challenges using engineering principles and data analytics
• Support technology transfer, manufacturing scale-up, and process optimization activities
• 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
• Provide engineering support during production scale-up, troubleshooting, and process improvements
• Assist laboratory personnel in developing new testing methods and validation protocols
• 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
• Represent MediTECH through ASTM, ORS, Biomaterials organizations, and other professional societies
• Deliver technical presentations and publish papers that position Mitsubishi Chemical as an industry leader
• 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
• Maintain confidentiality while ensuring compliance with quality, regulatory, and customer requirements
• Contribute to risk assessments, design controls, and technical documentation throughout the product lifecycle

What We're Looking For

• 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

Preferred Qualifications

• Experience with medical device design controls (21 CFR 820.30)
• Knowledge of FDA Quality System Regulations and ISO 13485
• Knowledge of 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