Sr. Mgr, Process Development, IE

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 https://www.jnj.com

Job Function:

R&D Operations

Job Sub Function:

Multi-Family R&D Operations

Job Category:

People Leader

All Job Posting Locations:

Danvers, Massachusetts, United States of America

Job Description:

We are searching for the best talent for a Senior Manager, Process Development, Innovation Exellence. An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

The Senior Manager, Process Development, Innovation Excellence is responsible for leading and playing pivotal enabling role towards process development and optimization that drives innovation and scalability of all commercial Impella pump products in collaboration with cross-functional teams. The role focuses on providing technical expertise, developing global standards and best practices, and building capability to enhance manufacturing performance, product quality, and compliance. The ideal candidate is a strategic thinker and a results-driven leader who thrives in complex environments combining deep process expertise and balancing creativity with analytical rigor to deliver measurable business outcomes.

Process Innovation & Continuous Improvement

• Lead initiatives that focus on process optimization and continuous improvement to enhance operational efficiency of commercial products.
• Responsible for process development and characterization in multi-functional lifecycle and critical sustaining projects (Scaleup, Automation, Yield, Obsolescence and 2nd source)
• Process subject matter expert support for internal technology transfer, installed capacity improvement, product development and process characterization of initiatives new initiatives.
• Work collaboratively with Product Engineering, Manufacturing, and Quality to identify and implement process solutions that enhance product performance and manufacturability.
• Serve as a subject matter expert in process development, advising teams on risk assessment, design-for-manufacturability and regulatory implications.

Sustaining, Quality and Compliance

• Process subject matter expert support for Production Engineering on non-standard production work, failure investigations and containment challenges.
• Act as second line of defense to support production on non-conformance escalations and complex failure investigations.
• Contribute to the development of standards, best practices, and technical documentation to ensure consistency and compliance across manufacturing locations.
• Responsible for process specific corrective actions in manufacturing area due to escalations, post-market surveillance complaints.
• Responsible for driving and support process specific CAPAs, DRAs and Internal Audit Observations ensuring compliance to meet QMS requirements.

Capability Building & Coaching

• Develop and deliver framework and best practices that enable systematic assessment, process characterization, validation and implementation of process enhancement.
• Define and monitor process performance metrics (KPIs) to track process improvements and ensure sustainability.
• Coach engineers and technical staff on structured problem-solving, statistical analysis, and process validation.
• Define and monitor process performance metrics (KPIs) to track process improvements and ensure sustainability.

Leadership & Collaboration

• Drive the integration of Lean, Six Sigma, and continuous improvement principles into engineering and manufacturing processes.
• Partner with cross-functional teams across global manufacturing sites to identify opportunities for process improvement in yield, efficiency, and reliability.
• Lead, mentor and develop cross-functional teams to execute process improvement and deliver sustainable results.
• Support project teams in the preparation of business cases, risk assessments, and validation documentation.

Required Qualifications

• Bachelor’s or Master’s degree in Mechanical, Chemical, Process or Industrial Engineering or a related field.
• 10+ years of experience in process development, manufacturing support, or continuous improvement within the medical device industry.
• Proven track record of leading cross-functional process development activities or innovation projects at scale across multiple sites.
• Passion for process innovation and enabling others to improve through knowledge sharing and technical mentorship.
• Ability to balance process innovation with operational discipline and compliance requirements.
• Demonstrated ability to manage resources, multiple business priorities and deliver under tight deadlines
• Strong analytical and problem-solving skills with expertise in data interpretation, statistical process control and capability analysis.
• Excellent leadership, communication, and stakeholder management capabilities.

Preferred Qualifications

• Lean Six Sigma Black Belt
• Deep knowledge of lean and structured problem-solving methodologies.
• Familiarity with medical device regulations (FDA 21 CFR Part 820, ISO 13485, EU MDR) and quality systems.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is $137,000 to $235,750.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. 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. For additional general information on Company benefits, please go to: -  https://www.careers.jnj.com/employee-benefits This job posting is anticipated to close on October 17, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.