Engineer II, Process Development, IE

Johnson & Johnson • Danvers, MA

64d • $89,000 - $143,750

About The Position

We are searching for the best talent for an Engineer II. 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 Engineer II, Process Development, Innovation Excellence supports the development, optimization, and improvement of manufacturing processes for commercial Impella pump products. This role contributes to cross-functional initiatives that enhance product performance, manufacturability, and compliance, while gaining experience in structured problem-solving and process engineering within a regulated environment. The ideal candidate is a hands-on engineer with a strong foundation in process development, eager to learn and grow through collaboration, data-driven analysis, and continuous improvement efforts.

Requirements

• Bachelor's in Mechanical, Chemical, Process or Industrial Engineering or a related field.
• 2-4 years of experience in process development, manufacturing support, or continuous improvement within the medical device industry.
• Strong passion for process innovation, with a commitment to knowledge sharing
• Ability to balance innovative thinking with operational discipline and regulatory compliance.
• Skilled in managing multiple tasks and delivering results in a fast-paced environment
• Strong analytical and problem-solving skills, including knowledge in statistical process control, capability analysis, and data interpretation.
• Excellent communication skills and collaborative mind et.

Nice To Haves

• Exposure to Lean Six Sigma methodologies; Green Belt certification is a plus.
• Familiarity with medical device regulations (FDA 21 CFR Part 820, ISO 13485, EU MDR).

Responsibilities

• Contribute to process development and improvement activities across lifecycle and sustaining projects, including scale-up, automation, and yield enhancement.
• Assist in executing process characterization and validation tasks under guidance from senior engineers.
• Collaborate with Product Engineering, Manufacturing, and Quality to implement process changes that improve efficiency and reliability.
• Support documentation and reporting of process development activities in alignment with regulatory and quality requirements.
• Participate in investigations of production issues and support containment and corrective actions.
• Assist in documenting process standards and best practices to ensure consistency across manufacturing sites.
• Lead and support CAPA actions and audit response activities by providing technical input and documentation.
• Apply structured problem-solving techniques (e.g., root cause analysis, 5 Whys) to support resolution of technical challenges.
• Monitor process performance metrics and contribute to data analysis for improvement opportunities.
• Work closely with cross-functional teams to support process development and validation efforts.
• Learn and apply Lean, Six Sigma, and continuous improvement principles in daily work.

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: Mid Level
• Number of Employees: 5,001-10,000 employees