Senior R&D Engineer
$100.9k - $126.2k/yr
Senior
Bachelor's
Fort Wayne, IN, USA
HybridHybrid schedule requires at least three days per week on-site in Fort Wayne; less than 25% travel.
Biology & BiotechBiomedical Engineering & Medical Devices
About the job
Requirements
- A bachelor's degree in Engineering or a related technical discipline is required.
- At least 5 years of experience in the orthopedic or medical device industry is required.
- Experience leading product development and engineering projects from concept through commercialization is required.
- A strong understanding of engineering principles related to product design, materials, and manufacturing processes is required.
- Experience reading and interpreting customer specifications and engineering drawings is required.
- Demonstrated project management experience and the ability to manage multiple priorities simultaneously are required.
- Strong analytical skills and experience using engineering and statistical analysis software, including Minitab, are required.
- Technical writing, presentation, and communication skills are required.
- The ability to collaborate effectively with customers, suppliers, and cross-functional teams is required.
- Self-motivation, leadership, and organizational skills are required.
- Proficiency with Microsoft Office and collaboration tools such as Microsoft Teams is required.
Responsibilities
- Lead research and development projects from concept through commercialization.
- Develop 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.
Desired Qualifications
- Experience with medical device design controls (21 CFR 820.30) is preferred.
- Knowledge of FDA Quality System Regulations and ISO 13485 is preferred.
- Experience with ISO 10993 biocompatibility standards is preferred.
- Knowledge of ISO 14971 risk management processes is preferred.
- Experience with Design History Files (DHF) and medical device documentation is preferred.
- Experience with implantable device materials, including metals, polymers, and surface treatments, is preferred.
- Experience creating FDA Master Files is preferred.
- A background in orthopedic implant materials or surgical applications is preferred.
About the company
MCGC supplies chemicals and advanced materials globally, including high-performance polymers, industrial gases (Nippon Sanso), and pharmaceuticals (Mitsubishi Tanabe Pharma), serving industries like automotive, semiconductor, aerospace, and healthcare. Its products rely on advanced chemical engineering and material science to create materials for electronics, mobility, and health, including carbon fiber composites, specialty polymers, and recyclable plastics. It differentiates itself with a massive global manufacturing footprint, deep technical expertise across chemicals, materials, and life sciences, and active open-innovation through Diamond Edge Ventures that integrates biotech and clean-tech startups into its ecosystem. The company aims to lead sustainable chemistry and advanced materials while pursuing net-zero emissions by 2050 and advancing a circular economy through decarbonization and scalable recycling.
Company Size
1,001-5,000
Company Stage
IPO
Headquarters
Tokyo, Japan
Founded
2005
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Simplify's Take
What believers are saying
- Mitsubishi Chemical launched ultra-high-purity colloidal silica and M-Filleris in August 2026.
- Audi selected DURABIO in 2026, proving automotive adoption for its bio-plastic platform.
- PsiQuantum and University of Tokyo partnerships expand its quantum-enabled materials discovery efforts.
What critics are saying
- FY2026 net income fell 73.7% to 11.8 billion yen, signaling fragile profitability.
- Tokai Plant epoxy shutdowns continue through September 2027, exposing aging-asset dependence.
- The 2025 Bain exit from Mitsubishi Tanabe Pharma removes a diversified earnings pillar.
What makes Mitsubishi Chemical Group unique
- Mitsubishi Chemical dominates specialty materials, industrial gases, and carbon fiber supply chains globally.
- Its 2026 semiconductor materials launches deepen customer qualification lock-in with chipmakers.
- KAITEKI and Diamond Edge Ventures link chemicals, climate tech, and startup scouting.
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Benefits
- Remote Work Options