Senior Development Engineer

RIVERPOINT MEDICAL LLC•Portland, OR

About The Position

Riverpoint Medical is hiring a Senior Development Engineer in Northeast Portland. The role develops products, processes, and test methods for surgical solutions, taking medical device concepts from initial ideas and prototypes through verification, validation, and market launch. Riverpoint Medical designs and manufactures premium medical devices for medical, dental, and veterinary markets, including suture technologies, sports medicine fibers and anchors, surgical lighting, and special needle technologies. The Senior Development Engineer plans and manages medical device design and development projects, including patient-specific products and associated manufacturing processes. The position works with customers and external contractors, maintains design control documentation, supports quality and regulatory requirements, and mentors other engineering staff. The role also manages project schedules, technical studies, cost estimates, and project barriers to support delivery on time and within budget.

Requirements

Bachelor's degree in Mechanical, Materials Science, Chemical, Electrical, or Biomedical Engineering.
At least 5 years of experience working with medical devices in development, reprocessing, and/or manufacturing.
At least 5 years of experience working in an FDA-regulated industry or field, or similar.
Prior CAD design experience using SolidWorks.

Nice To Haves

Experience with the FDA 510(k) process or other regulatory submissions.
Experience in a LEAN Manufacturing/Production environment, GMP, and/or New Product Development.

Responsibilities

Plan, conduct, and manage medical device design and development projects 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 schedules by studying project plans 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 contractors, including analytical laboratories, consultants, material suppliers, and equipment suppliers, and build effective relationships to meet delivery and budget goals.
Research and understand device functionality, device patents, and clinical use.
Design and develop products in compliance with Riverpoint Medical Design Control requirements per SOP820.030.
Maintain product design files, including testing, test reports, verification, validation, and design reviews.
Communicate with senior management to remove or escalate barriers that could impair project timelines or success.
Control project costs by approving expenditures and seeking upper-management authorization as needed.
Support company initiatives and requirements related to Quality Management Systems, Environmental Management Systems, and other regulatory requirements.