Principal NPI Engineer- Systems

Johnson & Johnson Innovative Medicine • Danvers, MA

5d

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Summary The Principal NPI Engineer – Supplier & Process Engineering (Systems) serves as the senior technical authority for supplier and manufacturing process industrialization across complex new product introduction (NPI) programs. This role sets strategy, defines standards, and leads execution to ensure new products launch with fully capable, scalable, and compliant manufacturing and supplier processes. The Principal NPI Engineer influences product design architecture, drives cross‑functional alignment, and leads manufacturing readiness, risk management, and supplier capability throughout the product lifecycle. This role operates with high autonomy, exercises seasoned technical judgment, and provides leadership across R&D, Manufacturing, Quality, Regulatory, and Supplier Engineering in a matrixed environment.

Requirements

• Bachelor’s or master’s degree in Mechanical, Biomedical, Electrical Engineering, or related technical discipline.
• 10–12+ years of experience in medical device R&D, NPI, manufacturing, or systems engineering.
• Proven track record leading complex products from concept through validation and production.
• Strong electromechanical systems knowledge with hands‑on troubleshooting capability.
• Intermediate CAD proficiency (SolidWorks preferred) and rapid prototyping experience.
• Experience with precision assembly processes and sourcing manufacturing tools and equipment.
• Proficiency with PLM systems, SAP (preferred), and data analysis tools (Minitab, MATLAB).
• Demonstrated ability to lead and influence cross‑functional teams without direct authority.
• Experience leading internal teams, suppliers, and external consulting resources.
• Strong project management skills with the ability to manage multiple parallel NPI programs.
• Expert communication skills, including executive‑level communication and ability to translate complex technical concepts to non‑technical audiences.
• Comfortable working independently with minimal supervision and exercising sound technical judgment.
• Experience operating effectively in a matrixed organization.
• Willingness to travel domestically and internationally (approximately 10–15%).
• Ability to work in a fast‑paced, ambiguous environment with shifting priorities.
• Highly collaborative while maintaining individual accountability.
• Persistent, structured problem solver who drives issues to true root cause.
• Comfortable challenging technical decisions when manufacturing or quality risks arise.
• Thrives in ambiguity and rapidly changing environments.
• Sense of Urgency: Moves quickly and decisively; acts without being prompted.
• Ownership: Takes full accountability for outcomes and proactively resolves issues.
• Transparency: Communicates directly and openly with no hidden agendas.
• Attention to Detail: Maintains technical rigor while driving execution.
• High Drive: Self‑motivated, resilient, and thrives under pressure and tight timelines.

Nice To Haves

• Experience with consoles, complex electromechanical systems, and DFM/DFX strongly preferred.
• Prior experience designing tooling, fixtures, and test automation solutions.
• Lean Manufacturing or Six Sigma certification with demonstrated application preferred.
• Working knowledge of cardiovascular physiology is a strong plus.

Responsibilities

• New Product Introduction & Manufacturing Readiness Lead end‑to‑end NPI execution from early concept through validation and production launch.
• Develop and maintain comprehensive manufacturing readiness frameworks for complex systems with large BOMs (100+ components).
• Drive cross‑functional NPI reviews with R&D, Quality, Supplier Engineering, and Operations to ensure seamless technology transfer and scale‑up.
• Create and execute aggressive NPI project timelines, proactively identifying risks and implementing mitigation strategies.
• Manufacturing Process Development & Validation Design, implement, validate, and document manufacturing processes, tooling, fixtures, gauges, and equipment (IQ/OQ/PQ).
• Lead development of precision assembly processes for complex electromechanical systems.
• Apply Lean Manufacturing and Six Sigma principles to improve yield, quality, throughput, and cost.
• Lead and participate in continuous improvement initiatives with measurable outcomes.
• Design for Manufacturability & Systems Integration Partner with R&D to drive DFM/DFA and DFX, ensuring product designs are compatible with manufacturing and supplier capabilities.
• Influence system architecture decisions to reduce risk and improve manufacturability.
• Oversee system integration of mechanical, electrical, instrumentation, and software components into functional systems.
• Electromechanical Troubleshooting & Root Cause Analysis Lead deep technical investigations to resolve complex manufacturing and build issues.
• Perform hands‑on electromechanical troubleshooting across mechanical, electrical, and instrumentation domains.
• Collect, analyze, and interpret process and product performance data to assess capability and drive improvements.
• Documentation, Compliance & Quality Develop and review manufacturing documentation including work instructions, BOMs, ECNs, design control records, lot history records, and quality system documentation.
• Partner with Quality to proactively identify and resolve non‑conformances before production impact.
• Ensure all manufacturing processes and documentation meet regulatory and compliance requirements.
• Supplier & Cross‑Functional Leadership Serve as the technical leader for supplier and process engineering across NPI programs.
• Establish strong working relationships with R&D, Development Engineering, QA, Supplier Engineering, and Production teams.
• Identify process requirements and support operations with equipment, tooling, and fixture implementation.
• Mentor and coach junior engineers and technicians, fostering a culture of technical rigor, ownership, and continuous improvement.

Benefits

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401k).
• This position is eligible to participate in the Company’s long-term incentive program.
• Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year.
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year.
• Holiday pay, including Floating Holidays – up to 13 days per calendar year.
• Work, Personal and Family Time - up to 40 hours per calendar year.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Number of Employees: 5,001-10,000 employees