Manager, Product Lifecycle

We are seeking a hands-on Engineering Manager to lead sustaining engineering and product development efforts within a growing medical device organization. This is a manager-level role focused on supporting and improving existing products rather than leading early-stage R&D.

The position oversees a small but growing team (currently 2 direct reports, expected to expand to 3+) and plays a critical role in ensuring products remain compliant, manufacturable, and aligned with current standards.

Key areas of focus include sustaining engineering, product updates (including acquired product lines), packaging changes, shelf-life extensions, and design control activities.

Key Responsibilities

Sustaining Engineering & Product Support

• Lead efforts to maintain and improve existing medical device products
• Drive design changes, updates, and enhancements to ensure compliance and performance
• Support packaging updates, shelf-life extensions, and product lifecycle initiatives
• Own design control processes, including documentation, testing, and regulatory alignment

Project Leadership

• Lead critical initiatives such as packaging changes and product updates from concept through implementation
• Oversee design verification, validation, and package integrity testing
• Ensure projects are executed efficiently and completed successfully

Acquisition Integration & Product Improvement

• Assess and improve newly acquired product lines
• Identify gaps in design, compliance, and documentation
• Implement best practices to bring products up to current standards

Team Leadership

• Manage and develop a team of engineers
• Set goals, lead project planning, and conduct regular 1:1s and performance reviews
• Foster a collaborative, high-performing team environment

Cross-Functional Collaboration

• Partner closely with Quality, Regulatory, Manufacturing, and Operations teams
• Identify issues, propose solutions, and drive continuous improvement initiatives

Qualifications

Required

• Bachelor’s degree in Engineering or related field
• 7+ years of experience in the medical device industry
• Strong knowledge of:
• Design Control
• Quality Management Systems (QMS)
• Experience working in FDA-regulated environments
• Proven ability to lead projects and drive initiatives to completion

Preferred

• Prior leadership or people management experience
• Experience in vascular or cardiovascular medical devices
• Familiarity with:
• ISO 13485
• ISO 14971 (risk management)
• Background in sustaining engineering or post-market product support