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

Ormco; Pomona (CA); On-site; USD 115,000 - 141,000; Full time

Job summary

Envista is seeking a Senior New Product Introduction (NPI) Engineer II in Pomona, CA. This onsite role collaborates with R&D, QA, regulatory, manufacturing, and product management to advance new product development and commercialization in compliance with quality systems and regulatory requirements.

The candidate will participate in design control, verification/validation, risk management, and design transfer, guiding projects through Phase-Gate processes and supporting commercialization

Qualifications

• 7+ years of engineering experience in medical device product development or related disciplines.
• Experience supporting medical device products through verification, validation, and design transfer in a Phase-Gate or similar process.
• Proven ability in design control activities, risk management, verification/validation, and design transfer.

Responsibilities

• Collaborate with R&D, QA, regulatory, manufacturing, product management, and supply chain across the product development lifecycle.
• Support Phase-Gate development activities and project deliverables.
• Participate in Design Control activities including planning, reviews, risk management, verification, validation, and transfer.
• Assist teams in meeting quality system and regulatory requirements.
• Develop, execute, and document engineering studies, tests, protocols, and reports.

Skills

Project management

Design controls

Regulatory affairs

Medical device engineering

Verbal communication

Education

Bachelor's degree in Mechanical Engineering

Job description

Job Summary

The

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.

IND123

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 range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.

For Field Sales roles, the salary range listed reflects base pay only and does not include incentive pay opportunities under the applicable sales compensation plan.

$115,400 - $141,000

Operating company:Ormco

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.

Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf