Senior Development Engineer

Riverpoint Medical Llc; Portland (OR); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical benefits

Dental and Vision

Life and AD&D insurance

401(k) with company match

Paid time off

8 paid holidays

Retention bonus

Annual bonus

Job summary

Riverpoint Medical in Northeast Portland is hiring a Sr. Development Engineer to drive medical device product development from concept to launch. You will develop products, processes, and test methods for premium devices used in medical, dental and veterinary markets, ensuring compliance with Riverpoint Design Control requirements.

The role emphasizes leading projects, collaborating with customers, and mentoring engineering staff while delivering on time and within budget.

Qualifications

• Bachelor's degree in a relevant engineering field.
• 5+ years in medical devices development, reprocessing or manufacturing.
• Experience with FDA-regulated environments and regulatory submissions.
• LEAN / GMP / New Product Development experience preferred.

Responsibilities

• Plan, conduct, 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 meet needs.
• Define project schedules, cost estimates, and ensure on-time delivery.
• Ensure compliance with QMS, EMS, and Riverpoint Design Control requirements.
• Mentor and coach engineering staff; engage external labs and suppliers as needed.
• Research device functions, patents, and clinical use; support design reviews.

Skills

Project leadership

Design for medical devices

FDA/Regulatory awareness

Lean, GMP experience

Education

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

Tools

Design Control

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.