BD · 1 day ago
Principal Engineer, New Product Introduction
Irvine, CA
Full-time
Onsite
Lead/Staff
$125K/yr - $206K/yr
8+ years expBD is one of the largest global medical technology companies in the world. The Principal Engineer, New Product Introduction (NPI) will lead the transition of new medical device products from design to commercial manufacturing, ensuring efficiency and quality throughout the product lifecycle.
Health CareMedical DeviceTechnical Support
Responsibilities
Lead and manage all technical aspects of new product introduction, from concept through commercial launch, ensuring adherence to project timelines, budgets, and quality standards
Collaborate extensively with R&D, Manufacturing, Quality, and Supply Chain teams to define and optimize manufacturing processes, equipment, and workflows for new products
Conduct DFM/DFA (Design for Manufacturability/Assembly) reviews, providing expert feedback to design teams to optimize product designs for efficient and high-quality production
Develop and implement robust manufacturing strategies, including process flow, equipment selection, tooling design, and automation solutions
Oversee process validation activities (IQ, OQ, PQ) for new manufacturing lines and equipment, ensuring compliance with regulatory requirements (e.g., FDA, ISO 13485)
Identify and mitigate potential manufacturing risks and issues early in the development cycle, implementing effective solutions and preventative measures
Drive continuous improvement initiatives for NPI processes, methodologies, and tools to enhance efficiency, reduce costs, and improve time-to-market
Provide technical leadership and mentorship to junior engineers and cross-functional teams, fostering a culture of innovation and excellence
Coordinate supplier selection and qualification processes, collaborating with suppliers to ensure robust material and component supply for new products
Qualification
Required
Bachelor's degree in Engineering (Mechanical, Biomedical, Industrial, or related field) required
Minimum 8 years of experience in medical device manufacturing, with at least 5 years specifically in New Product Introduction (NPI) or manufacturing process development roles
Demonstrated expertise in Design for Manufacturability (DFM) and Design for Assembly (DFA) principles
Strong understanding of manufacturing processes relevant to medical devices (e.g., injection molding, assembly, sterilization, packaging, automation)
Experience with process validation (IQ, OQ, PQ) and statistical process control (SPC)
Proven ability to lead complex technical projects and cross-functional teams
Excellent written and verbal communication skills, with the ability to present technical information clearly and concisely to diverse audiences
Strong problem-solving, analytical, and decision-making abilities
Ability to work effectively in a fast-paced, highly regulated environment
Preferred
Master's degree preferred
Familiarity with CAD software (e.g., SolidWorks, Creo) and GD&T principles is a plus
Knowledge of Six Sigma, Lean Manufacturing, and other continuous improvement methodologies
Ability to speak Spanish is preferred
Benefits
A valuable, competitive package of compensation and benefits programs
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Maureen Mazurek
Chief Sustainability and EHS Officer
Recent News
2026-01-22
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-01-20
Medical Device Network
2026-01-17
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