Senior R&D Engineer

Senior R&D Engineer - Bioprocessing / Single-Use Technology

Overview

We are seeking a highly experienced Senior R&D Engineer to lead the research, design, and development of complex components and assemblies supporting critical bioprocessing applications. This role drives innovation across the full product lifecycle - from concept and prototyping through validation and commercialization - while supporting rapid industrialization and scalable manufacturing.

Key Responsibilities
• Translate business objectives and market trends into innovative engineering solutions and product requirements.
• Lead end-to-end product development including planning, design, prototyping, testing, validation, and launch.
• Collaborate cross-functionally with engineering, scientific, quality, and operations teams within a structured stage-gate development process.
• Drive innovation by evaluating emerging technologies, materials, and design methodologies.
• Support intellectual property initiatives by identifying patentable concepts and working alongside legal teams.
• Manage project timelines, budgets, risks, and technical deliverables.
• Conduct risk assessments using FMEA and lead design and drawing reviews.
• Ensure compliance with applicable regulatory, safety, and quality standards.
• Analyze validation data and generate technical documentation including design history files and engineering reports.
• Champion design for manufacturability (DFM), cost optimization, and continuous product improvement.
• Author SOPs, work instructions, templates, and engineering documentation.
• Support Product Delivery Teams through CAPA activities, ECR/ECO processes, and quality documentation.
• Partner with internal and external technical experts to define design and manufacturing specifications.

Qualifications
• Bachelor's degree in Mechanical, Electrical, Biomedical, or related Engineering discipline (Master's preferred).
• 7+ years of engineering experience within biotechnology, pharmaceutical, or regulated manufacturing environments.
• 4+ years of Single-Use Technology (SUT) design experience; tubing, bags, or filling needle design experience preferred.
• Expertise in molded plastic part and fluid-handling assembly design.
• Strong knowledge of ISO 13485, ASME BPE, or comparable industry standards.
• Proven success delivering products from concept through commercialization.
• Experience with design controls, prototyping technologies (including 3D printing), testing, and validation.
• Advanced CAD proficiency (2D and 3D).
• Experience working within GMP or laboratory environments.
• Strong data analysis, technical writing, and problem-solving capabilities.
• Excellent communication skills with the ability to collaborate across all organizational levels.

Preferred Attributes
• Results-driven mindset with strong attention to detail and organizational skills.
• Ability to manage multiple projects in a fast-paced, collaborative environment.
• Proactive approach to continuous improvement and engineering excellence.