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 DESCRIPTION:

Johnson & Johnson is currently seeking a Sr. Process Development Engineer to join our Heart Recovery engineering team located in Danvers, MA.
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/.

Principle Duties and Responsibilities may include:

• Lead early-stage design & process development projects of novel hemodynamic support devices and accessories.
• Lead initiatives with engineers in research, product development, new product introduction and contract manufacturers or OEMs. Collaborate to deliver designs with margin to performance requirements and demonstrated process capability in scalable manufacturing processes.
• Conceptualize manufacturing methods, identify and install equipment, identify critical process inputs and outputs, develop processing windows and output specifications.
• Serve as Subject Matter Expert (SME) across platforms and lifecycle phases from research through sustaining teams.
• Collaborate with NPI process engineering to transfer design and processes into the production environment
• Train advanced technicians and operators on new processes, and updates to existing processes.
• Generate intellectual property through invention disclosures in pursuit of patients and trade secrets.
• Turn concepts into reality by rapidly prototyping using a variety of fabrication techniques.
• Test and iterate on your designs to develop an optimal solution.
• Bring solutions to market by collaborating with an exceptional cross-functional team.
• Conceptualize, design, prototype, procure, and build components and assemblies for products and testing/manufacturing fixtures.
• Conduct feasibility testing, analyze, and report on test results providing conclusions and recommendations.
• Perform failure investigations in the event of test failures with support from the technical team.
• Conduct voice of the customer and transform clinical observations into new device concepts and requirements

JOB QUALIFICATIONS:

• BS in Mechanical Engineering or directly related scientific discipline.
• 5+ years of related experience in medical device with 3+ years in manufacturing or new product introduction.
• Strong problem-solving skills and demonstrated experience identifying root cause of device failures.
• Demonstrated ability to execute tasks in a timely manner under minimal supervision.
• Willingness to learn the interventional cardiology space - the devices and the clinical practice.
• Experience applying statistical techniques and analysis.
• Willingness & ability to travel internationally ~5% of the time.

Strongly Preferred Qualifications:

• Experience in FDA Class II and III medical devices preferred.
• Experience in equipment and tooling design, fabrication, process development, and validation.
• Hands on experience in prototyping in pilot manufacturing and rapid prototyping; basic machine shop equipment preferred
• Experience in Solidworks 3D modeling, 2D drawing applying GD&T, PDM. Able to model complex parts and assemblies and conduct basic structural and fluid FEA.
• Hands on experience in testing in a laboratory environment
• Proficiency in scientific molding and other plastic processes including insert molding and complex engineered shafts
• Proficiency in laser-cutting, machining, coatings and finishing of metals and ceramics.
• Strong understanding of design control and risk management processes and deliverables
• Experience in design for manufacturing of plastic and metal components
• Strong understanding of statistical analysis of data, DOE’s, DMAIC, DFSS, Six Sigma Green Belt+

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
The anticipated base pay range for this position is $124,950 to $169,050.
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 March 31, 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.

• Lead early-stage design & process development projects of novel hemodynamic support devices and accessories.
• Lead initiatives with engineers in research, product development, new product introduction and contract manufacturers or OEMs. Collaborate to deliver designs with margin to performance requirements and demonstrated process capability in scalable manufacturing processes.
• Conceptualize manufacturing methods, identify and install equipment, identify critical process inputs and outputs, develop processing windows and output specifications.
• Serve as Subject Matter Expert (SME) across platforms and lifecycle phases from research through sustaining teams.
• Collaborate with NPI process engineering to transfer design and processes into the production environment
• Train advanced technicians and operators on new processes, and updates to existing processes.
• Generate intellectual property through invention disclosures in pursuit of patients and trade secrets.
• Turn concepts into reality by rapidly prototyping using a variety of fabrication techniques.
• Test and iterate on your designs to develop an optimal solution.
• Bring solutions to market by collaborating with an exceptional cross-functional team.
• Conceptualize, design, prototype, procure, and build components and assemblies for products and testing/manufacturing fixtures.
• Conduct feasibility testing, analyze, and report on test results providing conclusions and recommendations.
• Perform failure investigations in the event of test failures with support from the technical team.
• Conduct voice of the customer and transform clinical observations into new device concepts and requirement