Sr R&D Engineer

About the role

As a Senior R&D Engineer, you will drive the development of innovative medical products from conception to launch, ensuring adherence to R&D milestones. Your expertise will be crucial in researching and selecting medical-grade materials, identifying and resolving technical challenges, and coordinating with cross-functional teams to manage product development activities. This role requires a strong understanding of FDA Quality System Regulations (21 CFR 820), ISO 13485, and GMP standards, with a focus on design control, risk management, and maintaining comprehensive Design History Files.

Responsibilities

• Meet R&D milestones within the broader product launch schedule.
• Ensure raw materials meet medical-grade standards consistently.
• Identify milestone obstacles and develop solutions to well-defined technical problems.
• Conduct research on the structures and properties of materials (fibers, filaments, foams, films, nonwovens, wovens, adhesives, etc.) to obtain information that could be used to develop new products or enhance existing ones.
• Design a product within COGS (Cost of Goods Sold) targets.
• Coordinate with cross-functional teams (marketing, sales, manufacturing, sourcing, packaging, regulatory, etc.) as well as with nurses/clinicians to manage product development activities.
• Execute design control deliverables and support product risk management execution.
• Ensure products comply with claimed shelf-life, biocompatibility, and ‘material of concern’ requirements.
• Create and maintain DHF (Design History File) to ensure Product Lifecycle Management complies with internal/external audits.
• Support or execute design transfer for production.
• Lead projects and effectively communicate project status to team members and management.
• Participate in Maintenance of Business activities and support manufacturing facilities.
• Create and deliver effective multi-media presentations appropriate for cross-functional audiences.

Requirements

• Bachelor's degree in Biomedical, Mechanical, Plastics, or Materials Engineering preferred.
• Preferred Certifications: DFSS.
• 2+ years of product development experience in the medical device or regulated disposables industry preferred.
• Knowledge of FDA Quality System Regulations (21 CFR 820), ISO 13485, and GMP standards.
• Proficiency with statistical analysis software (preferably Minitab) and risk analysis tools.
• Experience with PLM Software.

Pay

Anticipated salary range: $90,200 - $115,830.

Benefits

• Medical, dental, and vision coverage.
• Paid time off plan.
• Health savings account (HSA).
• 401k savings plan.
• Access to wages before payday with myFlexPay.
• Flexible spending accounts (FSAs).
• Short- and long-term disability coverage.
• Work-Life resources.
• Paid parental leave.
• Healthy lifestyle programs.