Ormco Senior New Product Implementation Engineer II (Pomona, CA)

Primary Duties & Responsibilities

• Collaborate with R&D, Quality Assurance, Regulatory Affairs, Manufacturing, Product Management, Procurement, and Supply Chain teams throughout the product development lifecycle.
• Support product teams through Phase-Gate development activities and associated project deliverables.
• Participate in Design Control activities including development planning, design reviews, risk management, verification, validation, design transfer, and change management.
• Assist project teams in meeting internal quality system requirements and applicable regulatory requirements.
• Develop, execute, and document engineering studies, test methods, protocols, and technical reports in support of product development activities.
• Support verification and validation testing activities to demonstrate compliance with product requirements and design specifications.
• Support design transfer activities and collaborate with Manufacturing, Quality, and Supply Chain teams during commercialization efforts.
• Contribute to project planning, milestone tracking, and development deliverables.
• Provide technical guidance and mentorship to junior engineers and technicians as needed.

Job Requirements

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or related Engineering disciplines.
• 7+ years of engineering experience in medical device product development, new product introduction, quality engineering, manufacturing engineering, or related disciplines within a regulated environment.
• Demonstrated experience supporting medical device products through verification, validation, design transfer, commercialization, and production launch activities within a Phase-Gate or similar product development process.
• Experience participating in Design Control activities, including risk management, design reviews, verification and validation, traceability, and design transfer.
• Strong technical writing, verbal communication, problem-solving, and organizational skills.
• Possess Medical device industry experience working knowledge of FDA medical device regulations, including Design Controls, Quality System requirements, and 510(k) product development considerations.

Preferred Qualifications

• Understanding of EU MDR requirements and their impact on product development, risk management, verification and validation, and technical documentation.
• Familiarity with FDA, EU MDR, ISO 13485, and ISO 14971.
• Understanding of Design for Manufacturability (DFM), Design for Assembly (DFA), and Design Transfer principles.
• Electro-mechanical product development experience is highly desirable, including integration of mechanical components with motors, sensors, actuators, electronics, controls, or other electromechanical systems.

Success Factors

• Leads with a Continuous Improvement Mindset: Looks for opportunities to continuously improve processes and workflow, utilizing Envista Business Systems (EBS); is good at figuring out what to measure to track progress; sets up visual management systems to track progress and facilitate problem solving; is a master at the effectiveness and efficiency of work systems; can quickly diagnose and fix a workflow problem.
• Results Oriented: Address problems with drive and energy with an eye on results, costs and the bottom line; focuses on actions and outcomes; drives to finish everything s/he starts.
• Manages Diverse Relationships: Relates well to a wide variety of diverse styles and is open to differences; effective up, down, sideways, inside, and outside; builds diverse networks; quick to find common ground; Interpersonally agile; easy to approach and talk to; relates well to all kinds of people.