Senior Medical Device Development Engineer

Riverpoint Medical, LLC; Portland (OR); On-site; USD 120,000 - 165,000; Full time

Benefits offered by this job

Medical, Dental and Vision

401(k) with company match

Paid Time Off and holidays

Retention/Annual Bonus programs

Job summary

Riverpoint Medical, LLC in Portland, OR seeks a Sr. Development Engineer to drive medical device development from concept through verification, validation and launch.

You will lead design projects, mentor staff, and coordinate with customers and external partners to ensure on-time, compliant delivery. The role emphasizes design controls, regulatory submissions, and continuous improvement within a Lean GMP environment.

Qualifications

• Bachelor’s degree in an engineering discipline related to medical devices.
• 5+ years of experience with medical devices: development, reprocessing and/or manufacturing.
• 5+ years in FDA-regulated industry or similar environment.
• Experience with FDA 510(k) submissions preferred.
• LEAN manufacturing, GMP or New Product Development experience preferred.

Responsibilities

• Plan and manage design and development projects for medical devices.
• Lead development of patient-specific products and manufacturing processes.
• Maintain dialogue with customers to determine requirements and ensure needs are met.
• Define project schedule, time Requirements, and sequencing.
• Conduct technical studies and prepare cost estimates.
• Ensure compliance with QMS, EMS and regulatory standards.
• Mentor and coach engineering staff; collaborate with external vendors as needed.
• Engage analytical labs, consultants, and suppliers to meet timelines and budgets.
• Research device functionality, patents, and clinical use; support design reviews.
• Maintain Riverpoint design files and ensure traceability per SOP820.030.
• Escalate barriers to leadership and help remove obstacles to schedule.
• Support company initiatives and regulatory requirements.

Skills

Project management

Leadership

Mentoring

Customer communication

Design controls

Regulatory compliance

Cost estimation

Education

Bachelor’s degree in Mechanical, Materials Science, Chemical, Electrical or Biomedical engineering

Job description

Riverpoint Medical, LLC in Portland, OR seeks a Sr. Development Engineer to drive medical device development from concept through verification, validation and launch.

You will lead design projects, mentor staff, and coordinate with customers and external partners to ensure on-time, compliant delivery. The role emphasizes design controls, regulatory submissions, and continuous improvement within a Lean GMP environment.