Lead Development Engineer, Medical Devices Sutures

Teleflex; Mansfield (MA); On-site; USD 111,000 - 166,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k) plan

Job summary

Teleflex is seeking an Engineer III, Development to lead execution of medical device development projects in sutures and related devices across Mansfield, MA and nearby facilities. You will drive design control, risk management, and manufacturing readiness, collaborating with cross-functional teams to deliver compliant products on schedule.

The role emphasizes project management, ISO/GMP compliance, root-cause analysis, and continuous improvement.

Qualifications

• Bachelor's degree in engineering or related technical discipline.
• 4+ years in medical device or related field (5+ years preferred).
• 4+ years leading projects and/or project deliverables (5+ years preferred).
• Knowledge of FDA GMP and ISO requirements for design, validation, and manufacturing of medical components/devices.
• Experience with customer-facing interaction is preferred.
• PMP certification is a plus.

Responsibilities

• Plan, lead and manage projects and manufacturing engineering activities of moderate to low complexity independently.
• Lead development of products to minimize variation, scrap rates and productivity across the manufacturing process.
• Develop custom devices, sutures and subassemblies according to design and quality specs; on time and within project constraints.
• Identify and manage project scope with understanding of interdependencies.
• Draft and route project initiation/closure documents per procedures and regulations with minimal guidance.
• Interface with cross-functional teams to maintain accountability and deliverables.
• Serve as central contributor to continuous improvement initiatives.
• Predict project requirements, costs, lead times, and delivery schedules during quoting and execution.
• Apply structured project management principles to plan and execute projects of varying complexity.
• Lead quoting exercises for components and projects with minimal guidance.
• Review and adjust status reports, schedules, and project plans for high complexity as needed.
• Manage stakeholder communication with sales and customer care for updates.
• Utilize lean principles in project, process, and resource management.

Skills

Project management

Lean/6σ

Design controls

Cross-functional collaboration

Root cause analysis

Education

Bachelor of Science in Engineering

Tools

Microsoft Office

Project

Job description

Teleflex is seeking an Engineer III, Development to lead execution of medical device development projects in sutures and related devices across Mansfield, MA and nearby facilities. You will drive design control, risk management, and manufacturing readiness, collaborating with cross-functional teams to deliver compliant products on schedule.

The role emphasizes project management, ISO/GMP compliance, root-cause analysis, and continuous improvement.