Senior Electrical Manufacturing Engineer

About the Role

We are seeking an experienced and highly skilled Senior Electrical Manufacturing Engineer to lead and drive the development, optimization, and sustaining of complex PCBA manufacturing processes within a highly regulated medical device environment. This senior-level role requires deep technical expertise, strong leadership capabilities, and a proven track record of delivering high-quality PCBA solutions for life-critical medical products. The ideal candidate will serve as a technical subject matter expert (SME), driving continuous improvement initiatives, leading cross-functional teams, and ensuring that all PCBA processes meet the most stringent quality, reliability, and regulatory standards in the medical device industry.

Advanced Process Engineering & Development

• Lead the design, development, validation, and continuous improvement of complex PCBA manufacturing processes including SMT, through-hole, reflow soldering, wave soldering, selective soldering, and advanced cleaning processes
• Drive process capability improvements using statistical methods and advanced engineering techniques to achieve best-in-class yields and quality metrics
• Own and lead full process qualification and validation (IQ/OQ/PQ) activities from planning through execution and approval
• Develop and implement Design for Manufacturability (DFM) and Design for Assembly (DFA) guidelines and ensure adoption by design engineering teams
• Lead advanced root cause analysis for complex, recurring, or high-impact PCBA manufacturing failures
• Evaluate, qualify, and implement new materials, equipment, and technologies to improve process performance and competitiveness
• Define and own process control plans, FMEAs, and control strategies for critical PCBA processes

New Product Introduction (NPI) Leadership

• Serve as the primary PCBA manufacturing engineering lead for NPI programs, from concept through full production transfer
• Lead manufacturing readiness reviews and ensure all PCBA processes are production-ready prior to launch
• Collaborate with R&D and design engineering teams during early-stage development to influence PCB layout, component selection, and assembly design decisions
• Define pilot build strategies, process qualification plans, and production ramp activities
• Develop and present manufacturing risk assessments and mitigation strategies to program leadership

Technical Leadership & Mentorship

• Serve as the technical SME for all PCBA process-related topics across the organization
• Mentor and coach junior and mid-level manufacturing engineers, technicians, and operators
• Lead technical reviews, design reviews, and process audits with internal and external stakeholders
• Develop and deliver training programs on PCBA processes, IPC standards, and quality requirements
• Represent manufacturing engineering in cross-functional core teams and program reviews

Quality, Compliance & Risk Management

• Ensure all PCBA processes comply with IPC standards (IPC-A-610, IPC-7711/7721, IPC-J-STD-001) and medical device regulatory requirements
• Lead CAPA investigations and drive systemic corrective actions for PCBA-related non-conformances and customer complaints
• Own process-level risk management activities in accordance with ISO 14971
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, IEC 60601, and other applicable standards
• Support regulatory submissions, internal audits, and external inspections (FDA, Notified Body) related to PCBA manufacturing
• Drive implementation of Statistical Process Control (SPC) and key process indicators (KPIs) to monitor and control PCBA process performance

Supplier & Contract Manufacturer Management

• Lead qualification and ongoing oversight of contract manufacturers (CMs) and PCBA suppliers
• Conduct supplier audits and technical reviews to assess process capability and quality performance
• Define supplier quality requirements and collaborate with supply chain to resolve supplier-related PCBA issues
• Evaluate and approve material and component changes from a manufacturing process perspective

Continuous Improvement & Innovation

• Champion Lean Manufacturing and Six Sigma methodologies to drive waste reduction and process efficiency
• Lead or participate in kaizen events, value stream mapping, and other continuous improvement initiatives
• Identify and implement automation and digitalization opportunities in PCBA manufacturing processes
• Track and report on yield, defect rates, cycle time, and other key PCBA process metrics

Required Qualifications

Requires a bachelor's degree and minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience.

Preferred Qualifications

• 8–12+ years of progressive experience in PCBA manufacturing engineering
• 5 years of experience in a regulated medical device, aerospace, or defense manufacturing environment
• Demonstrated experience leading NPI programs and complex process validation activities
• Expert in SMT & Through-Hole Assembly Processes
• Expert in IPC Standards (IPC-A-610, J-STD-001)
• Expert in Reflow, Wave & Selective Soldering
• Expert in AOI, X-Ray & SPI Inspection Systems
• Expert in DFM / DFA Principles & Application
• Expert in IQ/OQ/PQ Process Validation
• Expert in FDA 21 CFR Part 820 / ISO 13485
• Expert in FMEA & Risk Management (ISO 14971)
• Expert in Root Cause Analysis (8D, 5-Why, DOE)
• Expert in Statistical Process Control (SPC)
• Expert in Conformal Coating & Cleaning Processes
• Six Sigma / Lean Manufacturing
• ERP / MES Systems (SAP, Oracle)
• Contract Manufacturer Management
• Proven ability to lead cross-functional teams and influence without direct authority
• Strong project management skills with the ability to manage multiple priorities simultaneously
• Excellent analytical and problem-solving capabilities with a data-driven approach
• Outstanding written and verbal communication skills, including the ability to present to senior leadership
• Demonstrated ability to mentor and develop junior engineering talent
• Strong collaboration skills with the ability to work effectively across R&D, Quality, Supply Chain, and Regulatory teams
• Master's degree in Electrical Engineering, Manufacturing Engineering, or related field
• IPC-A-610 Certified Trainer (CIT) or IPC Specialist certification
• Six Sigma Green Belt or Black Belt certification
• PMP (Project Management Professional) certification
• Experience with implantable or active medical devices (e.g., insulin pumps, neurostimulators, cardiac devices)
• Knowledge of RoHS, REACH, and environmental compliance requirements
• Experience with automated optical inspection (AOI) programming and optimization
• Familiarity with Industry 4.0 / Smart Manufacturing technologies
• Background in ESD control program development and management
• Experience supporting FDA inspections or Notified Body audits

Work Environment

• Fast-paced, highly collaborative medical device manufacturing environment
• Combination of office-based engineering work and hands-on production floor activities
• May require occasional travel to supplier sites, contract manufacturers, or global facilities (up to 15–20%)
• Clean room and ESD-controlled manufacturing environments
• Opportunity to work on cutting-edge medical technologies that directly improve patient outcomes