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.