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About the Role
Riverpoint Medical in Northeast Portland is hiring a Sr. Development Engineer to develop products, processes, and test methods for superior surgical solutions. This role transforms medical device concepts from ideas to market launch, contributing to innovations in the Medical, Dental, and Veterinary markets.
Responsibilities
- Plan, conduct, and manage design and development projects for medical devices.
- Lead the development of new patient-specific products and associated manufacturing processes.
- Maintain dialogue with customers to determine product requirements and ensure needs are met.
- Determine project schedules by studying project plans and specifications.
- 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 for project needs and build effective relationships with resources.
- Research and understand device functionality, patents, and clinical use.
- Design and develop products in compliance with Riverpoint Medical Design Control requirements and maintain design files.
- Communicate with senior management to remove barriers and escalate obstacles.
- Control costs by approving expenditures and seeking authorizations.
- Support company initiatives related to 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.
- 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.
Skills
- CAD using SolidWorks
- FDA 510(k) process
- LEAN Manufacturing/Production environment
- GMP
- New Product Development
Location
- Northeast Portland
Work Type
- Full-time
Experience Level
- 5+ years
Education Level
- Bachelor’s degree
Benefits
- Medical
- Dental
- Vision
- Life and Accidental Death Insurance
- 401(k) with company match and immediate vesting
- Paid Time Off
- 8 company paid holidays
- Bonus pay (Retention Bonus, Referral Bonus, Annual Bonus)
About the Company
- Riverpoint Medical specializes 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.
Equal Opportunity
- 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.