Senior Engineer Manufacturing Engineer

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:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

About Orthopaedics

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

Are you passionate about improving and expanding the possibilities of Orthopaedics Ready to join a team thats reimagining how we heal Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports extremities and elective foot and ankle; spine; and robotics and digital surgery.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months subject to legal requirements including consultation with works councils and other employee representative bodies as may be required regulatory approvals and other customary conditions and approvals.

Should you accept this position it is anticipated that following conclusion of the transaction you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes programs policies and benefit that case details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Job Description

The Senior Engineer Manufacturing Engineer applies sophisticated manufacturing engineering expertise to support and improve medical device production processes with particular emphasis on metals manufacturing and sterile packaging. This role combines technical subject matter expertise with project leadership leading complex initiatives involving process development process transfer equipment and process qualification validation statistical analysis and continuous improvement. The position requires strong hands-on manufacturing knowledge the ability to interpret drawings and critical-to-quality requirements and the capability to lead cross-functional projects that deliver compliant efficient and reliable manufacturing operations.

This individual partners closely with Quality R&D Regulatory Supply Chain Operations and external suppliers to implement manufacturing solutions resolve process issues and support new product handoff and sustaining activities. The role drives problem solving supports risk-based decision-making and leads improvement projects using Lean and Six Sigma methods. Success in this position requires someone who can influence across functions translate technical complexity into clear actions and serve as both a trusted project leader and a hands-on manufacturing SME.

Key Responsibilities:

• Lead complex projects aligned to business goals including product and process transfers process improvements and value improvement initiatives.

• Develop assess and refine business cases to confirm technical feasibility financial impact and strategic value.

• Present project recommendations to leadership to secure alignment approval and progression through applicable capital approval processes.

• Use Lean should-cost modeling and related tools to identify cost of goods and value capture opportunities and lead those opportunities from conceptualisation through implementation.

• Serve as the technical subject matter expert for manufacturing processes supporting medical devices including metals processing and packaging operations.

• Lead process change initiatives supporting optimization and troubleshooting activities to improve capability yield quality and operational efficiency at internal sites and key external suppliers.

• Interpret and apply engineering drawings specifications CTQs and process documentation to ensure robust manufacturing and inspection practices.

• Develop and execute validation strategies including IQ/OQ/PQ and support associated documentation in compliance with applicable quality system and regulatory requirements.

• Apply statistical methods and data analysis to support process qualification capability assessment investigations monitoring and continuous improvement activities.

• Lead structured problem solving and improvement initiatives using Lean Six Sigma and risk-based methodologies to improve quality throughput and cost performance.

• Support capital and process improvement projects by defining technical requirements evaluating solutions and leading implementation across cross-functional teams.

• Collaborate with Quality and Operations to define inspection methods process controls and acceptance criteria aligned with product requirements and manufacturing capability.

• Author and support risk-based documentation related to process changes validation activities and manufacturing controls.

• Provide technical coaching and guidance to engineers technicians and operations partners and contribute to broader team and business priorities as needed.

Qualifications:

Education:

• Minimum of a Bachelors degree and/or University degree is required; focused degree in Engineering preferred. An advanced degree is preferred.

Required:

• A minimum of eight (8) years of meaningful professional experience is required; ten (10) or more years is preferred including hands-on manufacturing experience in regulated medical device environments.

• Strong manufacturing expertise with hands-on experience in medical device manufacturing processes including metals and sterile packaging is required.

• Demonstrated experience leading cross-functional technical projects from scoping through implementation is required.

• Demonstrated experience with process validation including IQ/OQ/PQ and solid understanding of validation requirements within a regulated manufacturing environment is required.

• Proven track record to interpret and apply engineering drawings specifications CTQs and inspection methods is required.

• Strong understanding of statistics and the application of data-driven methods to process control qualification problem solving and continuous improvement is required.

• Experience with risk documentation and risk-based decision-making in support of manufacturing and validation activities is required.

• Excellent written and verbal communication skills with the ability to influence and work optimally across engineering quality operations and leadership teams are required.

• Strong interpersonal skills and capability to lead multiple technical priorities and projects are required.

Preferred:

• Lean Six Sigma Green Belt certification or training is preferred.

• FPX-qualified project leadership experience is preferred.

• Experience leading cross-functional manufacturing transfer or process improvement projects in a medical device environment is highly preferred.

• Knowledge of Lean manufacturing DMAIC should-cost modeling and advanced statistical analysis tools is highly preferred.

• Broad understanding of manufacturing inspection methods process capability and control strategies is preferred.

• Solid understanding of medical device regulatory and quality system requirements is preferred.

• Experience supporting manufacturing processes subject to validation compliance and audit expectations in FDA-regulated environments is preferred.

Other:

• May require up to 20% domestic and/or international travel to other locations and sites

#indjp

#LI-CM4

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is:

Benefits:

In addition to base pay we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location where the actual amount is based on the employees and companies performance of the previous calendar year or sales commissions. Moreover we offer vacation days parental leave for a minimum of 12 weeks bereavement leave caregiver leave volunteer leave well-being reimbursement programs for financial physical and mental health. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans. For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.