Sr. Site Transfer Manufacturing Engineer Shockwave Medical

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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 Function:

Supply Chain Engineering

Job Sub Function:

Manufacturing Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Santa Clara California United States of America

Job Description:

Johnson & Johnson is hiring for aSr. Site Transfer Manufacturing Engineer - Shockwave Medicalto join our team located inSanta Clara CA.

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments. Ready to join a team thats pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

The Sr. Site Transfer Manufacturing Engineer leads and executes product and process transfers between manufacturing sites (domestic and international) ensuring successful compliant and timely ramp of on-market products. This role is the primary technical lead for multi-site transfers coordinating crossfunctional teams (R&D QE Regulatory Supply Chain Production and External Partners) to deliver validated robust manufacturing processes at the receiving site.

Essential Job Functions

• Lead end-to-end site-to-site transfer projects from transfer planning and risk assessment through validation production ramp and post-transfer monitoring.

• Create and manage detailed Transfer Plans and timelines including resource needs milestones deliverables and go/nogo criteria.

• Develop and maintain process pFMEAs risk mitigation plans and transfer-specific mitigation actions.

• Define user and functional requirements for equipment and systems at the receiving site; lead equipment qualification and installation activities (IQ/OQ/PQ).

• Oversee process validation and qualification activities at both sending and receiving sites; ensure data integrity and compliance with protocols.

• Coordinate crosssite documentation transfer: BOMs work instructions MPIs LHRs configuration control and design control elements as applicable.

• Lead or participate in system integrations required for transfer (MES/ERP/PLM) including data migration validation and enduser training.

• Plan and execute capability studies (Cpk) DOE tolerance analyses and other statistical evaluations to demonstrate process equivalency and capability at the receiving site.

• Collaborate with Supply Chain and Procurement to ensure material component and supplier readiness; qualify alternate suppliers when needed.

• Provide technical leadership during production ramp: troubleshooting root-cause analysis (DMAIC) corrective actions and optimization to achieve targeted yields and throughput.

• Define and track relevant transfer KPIs (e.g. schedule adherence yield Cpk cost variance) and report status to stakeholders and leadership.

• Mentor and coach engineers and technicians on site transfer best practices and regulatory requirements.

• Support regulatory submissions audits and inspections related to transferred products and processes.

• Travel between sites as required to lead transfers and support on-site validations and training.

Requirements

• Bachelors degree in Mechanical Biomedical Industrial Manufacturing Engineering or closely related field. Masters degree may substitute for 12 years of experience.

• 57 years of hands-on manufacturing engineering experience in a regulated industry (medical device preferred; pharmaceutical automotive or similar industries acceptable).

• Direct experience in site-to-site or product/process transfers (documented role as lead or co-lead on at least one transfer or multiple process transfer projects).

• Practical experience with process validation and equipment qualification (IQ/OQ/PQ) and executing transfer validation protocols.

• Strong understanding of Quality System Regulations and standards (QSR/FDA ISO 13485 MDR) as they apply to transfers and design control.

• Proficiency in statistical methods and tools: capability studies (Cpk) basic DOE and use of statistical software (Minitab or equivalent).

• Hands-on familiarity with MES ERP and/or PLM systems and experience supporting data migration or configuration for transfers.

• Competency with CAD tools (SolidWorks or similar)

• Demonstrated project management skills: develop transfer plans schedules resource allocation risk assessments and status reporting.

• Strong problem solving using structured methods (DMAIC root cause analysis) and experience implementing corrective/preventive actions.

• Excellent written and verbal communication skills; experience preparing technical reports transfer documentation and training materials.

• Ability and willingness to travel to partner sites (up to 2535% depending on project load).

• Ability to occasionally lift up to 25 lbs.

Preferred Qualifications

• Six Sigma Green Belt or Black Belt or equivalent continuous improvement certification.

• Experience with tolerance analysis and performing detailed pFMEA for transfer risk mitigation.

• Prior work with global transfers or contract manufacturers/CMOs.

• Experience performing cost and productivity analyses (time studies labor/material costing) to support transfer decisions.

• Formal project management certification (PMP or equivalent) or demonstrated multi-project leadership experience.

• Experience mentoring junior engineers and leading crossfunctional transfer teams.

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as assigned or negotiated to meet the ongoing needs of the organization.

Additional Information

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Companys long-term incentive program.

Subject to the terms of their respective policies and date of hire employees are eligible for the following time off benefits:

• Vacation 120 hours per calendar year

• Sick time - 40 hours per calendar year

• Holiday pay including Floating Holidays 13 days per calendar year

• Work Personal and Family Time - up to 40 hours per calendar year

• Parental Leave 480 hours within one year of the birth/adoption/foster care of a child

• Bereavement Leave 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

• Caregiver Leave 80 hours in a 52-week rolling period10 days

• Volunteer Leave 32 hours per calendar year

• Military Spouse Time-Off 80 hours per calendar year

For additional general information on Company benefits please go to: - Skills:

Preferred Skills:

Accelerating Analytical Reasoning Coaching Communication Facility Management Good Manufacturing Practices (GMP) Lean Manufacturing Principles Lean Supply Chain Management Manufacturing Engineering Manufacturing Science and Technology (MSAT) Problem Management Project Engineering Project Schedule Report Writing Safety-Oriented Science Technology Engineering and Math (STEM) Application Technologically Savvy

The anticipated base pay range for this position is :

$91000.00 - $147200.00

Additional Description for Pay Transparency: