Staff Product Development Engineer

A leading medical device manufacturer is seeking a Staff Quality Engineer to support new product development and sustaining engineering activities for innovative combination products.

This role will focus on drug-coated balloon technology used to treat peripheral artery disease and requires deep expertise in integrated combination products where the therapeutic drug component is physically incorporated into the medical device.

This is a highly cross-functional position that combines technical leadership, risk management, product development, and manufacturing support across both medical device and pharmaceutical operations. The ideal candidate will bring a strong understanding of design controls, risk-based decision making, and regulatory compliance within a regulated healthcare environment.

Key Responsibilities

• Provide technical leadership for new product development and sustaining engineering initiatives related to combination products
• Support product lifecycle activities including manufacturability, scalability, manufacturing transfer, and post-launch sustainability
• Lead development and execution of risk assessments, including risk management files and risk-based decision making
• Develop, support, review, and investigate analytical and physical test methods for pharmaceutical combination devices
• Lead activities related to:
• Component qualification
• Design verification and validation
• Drug stability studies
• Process validation
• Product investigations
• Evaluate product and process changes against design requirements and risk profiles
• Translate design inputs into manufacturing control plans and product specifications
• Collaborate cross-functionally with Product Development, Quality, Regulatory, Manufacturing, and Supply Chain teams
• Support Chemistry, Manufacturing, and Controls (CMC) documentation and regulatory submissions
• Represent Quality Engineering on product development and design review teams
• Prepare and present technical updates, project milestones, and risk assessments to internal stakeholders
• Participate in project planning activities including budgeting, scheduling, and project tracking
• Support internal and external supplier audits
• Develop and implement procedures aligned with corporate policies and industry standards
• Ensure compliance with applicable company procedures, FDA regulations, and international standards
• Provide training support and mentorship related to procedures, policies, and quality expectations
• Travel up to 25% as needed for business, project support, and issue resolution

Qualifications

• Bachelor’s degree in Engineering, Biological Sciences, or related technical discipline
• 8 years of engineering experience within the medical device, pharmaceutical, or combination product industry
• Strong experience supporting pharmaceutical-device combination products
• Proven expertise in medical device design controls and product development processes
• Experience leading creation and maintenance of risk management documentation
• Working knowledge of:
• Test method development and validation
• Equipment qualification
• Process and design validation
• Component qualification methodologies
• Statistical analysis and risk assessment techniques
• Familiarity with product design, prototyping, and manufacturing processes
• Strong understanding of regulatory and quality standards including:
• ISO 13485
• ISO 14971
• 21 CFR 210/211/820
• ICH Guidelines
• Excellent communication, collaboration, and technical leadership skills
• Ability to develop practical, business-focused engineering solutions in a highly regulated environment

Salary $100,000 - $120,000 12% Bonus and Relocation if needed