Development Engineer I

Responsibilities

• Plan, conduct, and manage design and development projects for medical devices in support of the company's strategic plan.
• Lead 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.
• Determine project schedule by studying project plan and specifications, calculating time requirements, and sequencing project elements.
• Complete technical studies and prepare cost estimates.
• 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, or biomedical engineering or similar or equivalent work experience
• 1-3 years’ experience working in a controlled manufacturing or development environment

Preferred Qualifications

• 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
• Life and Accidental Death Insurance
• 401(k) with company match and immediate vesting
• Paid Time Off and 9 company paid holidays
• Bonus pay such as Referral Bonus and Annual Bonus