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

envista; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Envista in Pomona, CA is seeking a Senior New Product Introduction Engineer II to support new product development from feasibility to launch; collaborates with R&D, QA, Regulatory, Manufacturing, and more to ensure quality systems and regulatory compliance.

Requires 7+ years in medical device development, hands-on design control, verification/validation, and design transfer; on-site four days a week.

Qualifications

• Bachelor's degree in a relevant engineering discipline.
• 7+ years of medical device development experience.
• Experience with verification, validation, design transfer, and product launch.
• Knowledge of FDA medical device regulations (Design Controls, QSR).

Responsibilities

• Collaborate across R&D, QA, regulatory, manufacturing, and supply chain.
• Support Phase-Gate development activities and deliverables.
• Lead design control activities including planning, reviews, risk management.
• Document studies, tests, reports to support development.
• Mentor junior engineers and technicians.

Skills

Medical device experience

Phase-Gate process

Design Control

Verbal communication

Technical writing

Risk management

Education

Bachelor's degree in Engineering

Job description

Job Summary

The Senior New Product Introduction (NPI) Engineer II is a key member of the product development team responsible for supporting new product development and commercialization activities from feasibility through product launch. This role collaborates closely with Research & Development, Quality Assurance, Regulatory Affairs, Manufacturing, Supply Chain, and Product Management functions to help ensure products are developed in accordance with company quality systems, regulatory requirements, and business objectives.

The selected candidate must reside within a commutable distance to Pomona, CA. This is not a hybrid or remote opportunity and requires onsite presence 4 days per week.

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.

Other 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.

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Target Market Salary Range:

Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Envista, it is not typical for an individual to be hired at or near the top of the ra