Senior Engineer Manufacturing Engineer

Johnson & Johnson Innovative Medicine•West Chester, PA

17h•$94,000 - $132,000•Onsite

About The Position

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.

Requirements

Minimum of a Bachelor’s degree and/or University degree is required; focused degree in Engineering preferred.
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.

Nice To Haves

An advanced degree is 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.

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.