Senior 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

Full Time Portland, OR, US

Riverpoint Medical in Northeast Portland is hiring a Sr. Development Engineer. The Riverpoint Sr. Development Engineer will develop products, processes, and test methods to create superior surgical solutions. Transforming medical device concepts from ideas, to prototypes, through verification and validation, and launch to the market. At Riverpoint you will be part of the process that brings great technology to Medical, Dental and Veterinary markets. We specialize in the design and manufacturing of premium medical devices. Our ingenuity can be found in our suture technologies, sports medicine fibers and anchors, surgical lighting, and special needle technologies

Duties and Responsibilities

• Plan, conduct, and manage design and development projects for medical devices in support of the company's strategic plan.
• Leads to the development of new patient specific products and associated manufacturing processes.
• Maintain productive and respectful dialogue with customers to determine product requirements and ensure customer needs are met.
• Determines project schedule by studying project plan and specifications, calculating time requirements, and sequencing project elements.
• Completes technical studies and prepares cost estimates.
• Manage compliance, quality control, and quality assurance standards and specifications.
• Mentor, lead, and coach other members of the engineering staff
• Engage outside contracting services in support of project needs, i.e., analytical laboratories, consultants, material suppliers and equipment suppliers. Build effective relationships with these resources to meet delivery and budgetary goals.
• Research and understand device functionality, device patents, and clinical use.
• Design and develop products in full compliance with the Riverpoint Medical Design Control requirements per SOP820.030, and maintain design files for company products, including testing, testing reports, verification, validation, design files, and design reviews.
• Communicate with senior management to remove barriers/obstacles that could impair the project’s timeline and/or overall success. Escalate barriers/obstacles to the appropriate leader to keep the project on track, on time, and within budget. Control costs by approving expenditures and seeking authorizations from the upper management as needed.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Education and Qualifications

• Bachelor’s degree in Mechanical, Materials Science, Chemical, Electrical or Biomedical engineering
• 5+ years of experience working with medical devices; development, reprocessing and/or manufacturing
• 5+ years of experience working in an FDA regulated industry/field, or similar.
• Experience with FDA 510(k) process or other regulatory submissions preferred.
• Experience in a LEAN Manufacturing/Production environment, GMP and/or New Product Development preferred.

We offer great benefits: Medical, Dental and Vision, Life and Accidental Death Insurance; 401(k) with company match and immediate vesting, Paid Time Off and 8 company paid holidays. We also reward our team with bonus pay such as Retention Bonus, Referral Bonus and Annual Bonus!

Riverpoint Medical is committed to a diverse and inclusive workplace. Riverpoint Medical is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.