Development Engineer II

Riverpoint Medical Llc; Portland (OR); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k) with company match

Paid Time Off

9 company paid holidays

Bonus pay (referral and annual bonus)

Job summary

Riverpoint Medical in Northeast Portland is seeking a Development Engineer II to drive design and development projects for medical devices, from concept to prototype and testing. You will develop systems and processes to enhance our product portfolio, while maintaining design control documentation and regulatory compliance.

The role involves leading teams, mentoring engineers, and coordinating with customers and external suppliers to meet timelines and budgets.

Qualifications

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

Responsibilities

• Plan, conduct, and manage design and development projects for medical devices.
• Lead development of new patient-specific products and manufacturing processes.
• Maintain productive dialogue with customers to determine product requirements.
• Determine project schedule by studying plans and specs and sequencing elements.
• Complete technical studies and prepare cost estimates.
• Manage compliance, quality control, and quality assurance standards.
• Mentor, lead, and coach engineering staff.
• Engage external contracting services to meet project needs and budget.
• Research device functionality, patents, and clinical use.
• Design and develop products in compliance with Riverpoint Medical Design Control requirements.
• Support QMS, EMS, and other regulatory initiatives.

Skills

Controlled Manufacturing

FDA Regulated

Mentoring / Leadership

Education

Bachelor's degree in Engineering

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Full Time Portland, OR, US

Job Description

Riverpoint Medical in Northeast Portland is hiring a Development Engineer II. 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. The Riverpoint Development Engineer II will develop systems, processes, methodologies as well as product development to enhance our product offering. 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.
• 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.
• 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 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 9 company paid holidays. We also reward our team with bonus pay such as referral an 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.