Senior Development Engineer
RIVERPOINT MEDICAL LLC
Summary
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.
Job description
Duties and 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, 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 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
- Prior design experience in CAD using SolidWorks
- 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
Requirements
- 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
- Prior design experience in CAD using SolidWorks
- 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
Benefits
- Medical, Dental & Vision
- Life & Accidental Death Insurance
- 401(k) Matching
- Paid Time Off
- 8 Company Paid Holidays
- Retention Bonus
- Referral Bonus
- Annual Bonus
Company overview
Riverpoint Medical is a leading medical device manufacturer specializing in the design, development, and production of next-generation surgical solutions. Founded in 2008 and headquartered in Portland, Oregon, the company has grown from a small family-run business into a crucial player in the medical device manufacturing market. Riverpoint Medical stands out as one of the few remaining suture manufacturers in the United States, with particular expertise in synthetic absorbable and orthopedic suture materials. The company's product portfolio includes high-performance surgical sutures for both human and veterinary markets, orthopedic and sports medicine implants, high-strength fiber solutions, cordless LED surgical headlights, and brachytherapy products for oncology applications. With their proprietary HS Fiber® UHMWPE suture line for sports medicine, Riverpoint has established itself as a preferred partner for premium suture solutions. The company operates comprehensive facilities that support start-to-finish capabilities, including product design, engineering, R&D, material expertise, quality control, and regulatory compliance, enabling clients to bring innovative medical devices to market more efficiently.