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

Senior R&D Engineer

Are you an experienced R&D engineer with a passion for medical innovation and implantable materials? Mitsubishi Chemical Advanced Materials is seeking a Senior R&D Engineer to join our MediTECH Division, where you'll help develop the next generation of orthopedic implant materials and manufacturing technologies.

This is a highly technical, customer-facing leadership role that combines research, product development, project management, and process engineering. You'll lead new product and process development from concept through commercialization while collaborating with customers, suppliers, and cross-functional teams to bring innovative medical device solutions to market. If you're driven by solving complex engineering challenges and advancing healthcare technologies, we'd love to hear from you.

Lead new product and 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
• 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 and 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 and 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

• 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

• 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

• On-site or Hybrid opportunity
• Hybrid schedule requires a minimum of three days per week on-site in Fort Wayne, IN
• Less than 25% travel

• Develop innovative materials that improve patient outcomes around the world
• Lead high-impact R&D projects from concept through commercialization
• Collaborate with experts in engineering, manufacturing, quality, and regulatory affairs
• Represent Mitsubishi Chemical within leading medical and…