Develop Engineer II

About the role

Riverpoint Medical in Northeast Portland specializes in the design and manufacturing of premium medical devices for Medical, Dental and Veterinary markets, including suture technologies, sports medicine fibers and anchors, surgical lighting, and special needle technologies. The Development Engineer II will develop systems, processes, methodologies, and product development to enhance product offerings, transforming concepts into prototypes for testing, validation, and improvement for production.

Responsibilities

• Plan, conduct, and manage design and development projects for medical devices in support of the company's strategic plan.
• Lead 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.
• Determine project schedule by studying project plan and specifications, calculating time requirements, and sequencing project elements.
• Complete technical studies and prepare 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 (analytical laboratories, consultants, material suppliers, equipment suppliers) and build effective relationships to meet delivery and budgetary goals.
• Research and understand device functionality, device patents, and clinical use.
• Design and develop products in full compliance with 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.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Requirements

• Bachelor’s degree in Mechanical, Materials Science, Chemical, Electrical or Biomedical engineering.
• 3–5 years of experience working in a controlled manufacturing or development environment.
• 2–5 years of experience working in an FDA regulated industry/field, or similar.

Preferred Experience

• Experience working in an FDA regulated industry/field or similar.
• Exposure to the FDA 510(k) process or other regulatory submissions.
• Experience in a LEAN Manufacturing/Production environment, GMP and/or New Product Development.

Benefits

• Medical, Dental and Vision insurance
• Life and Accidental Death Insurance
• 401(k) with company match and immediate vesting
• Paid Time Off
• 9 company-paid holidays
• Bonus pay including referral and annual bonuses