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

Mitsubishi Chemical Group•Fort Wayne, IN

1d•$100,922 - $126,152•Hybrid

About The Position

Mitsubishi Chemical Advanced Materials is seeking a Senior R&D Engineer to join their MediTECH Division. This role focuses on developing next-generation 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 internal teams to bring innovative medical device solutions to market. The position is ideal for individuals driven by solving complex engineering challenges and advancing healthcare technologies.

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 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
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
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
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
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