About the role
Company
Mitsubishi Chemical Advanced Materials Inc.
Job Description: 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.
What You'll Do
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
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
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
Work Arrangement & Travel
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
Why Join Us?
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 biomaterials organizations
Help shape the future of orthopedic implant technologies
Join a global organization committed to innovation, quality, and scientific excellence
Competitive compensation and comprehensive benefits package
If you're a technically driven engineer with a passion for medical device innovation, product development, and solving complex engineering challenges, we encourage you to apply and help shape the future of orthopedic materials and technologies.
The salary range for this position is $100,922 - $126,152 USD Annual. Factors such as scope and responsibilities of the position, candidate's work experience, education/training, job-related skills, internal peer equity, as well as market and business considerations may influence base pay offered. This salary will be subject to a geographic adjustment (according to a specific city and state), if an authorization is granted to work outside of the location listed in this posting.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status
Mitsubishi Chemical Advanced Materials Inc. is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please email
MCA-MBX_accomodations@m-chem.com.
We will make a determination on your request for reasonable accommodation on a case-by-case basis.
The law requires Mitsubishi Chemical Advanced Materials Inc. to post a notice describing the Federal laws prohibiting job discrimination. For information regarding your legal rights and protections, please click on the following link:
Know Your Rights
Mitsubishi Chemical Advanced Materials Inc. will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay. Please see the
Pay Transparency Nondiscrimination Provision
for more information
As a Federal Contractor, Mitsubishi Chemical Advanced Materials Inc. is required to participate in the E-Verify Program to confirm eligibility to work in the United States. For information please click on the following link:
E-Verify
.